AESCULAP PM438RRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 04038653322862), received between Nov 3, 2020 and Dec 17, 2021 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (3 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryDec 17, 2021Material Fragmentation; Material Fragmentation

  INVOLVED COMPONENTS. PM973R - INSULATED OUTER TUBE 5/5MM 310MM - LOT UNKNOWN. PM450R - HANDLE FOR BIPOLAR INSTRUMENTS - LOT UNKNOWN.

  Patient problems: Foreign Body In Patient

  MAUDE report 13027644 ↗
• MalfunctionDec 10, 2021Break; Break

  CORRECTION / ADDITIONAL INFORMATION: PATIENT INJURY HAD OCCURRED AND PATIENT HARM WAS REPORTED AS "THE FRAGMENTS REAMINED IN SITU". ADDED INVOLVED COMPONENTS. THE FRAGMENT REMAINED IN SITU. INVOLVED COMPONENTS: PM450R - HANDLE FOR BIPOLAR INSTRUMENTS - LOT UNKNOWN. PM973R - INSULATED OUTER TUBE 5/5MM 310MM - LOT UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12975779 ↗
• MalfunctionJul 13, 2021Break; Break

  IT WAS REPORTED TO AESCULAP AG THAT A JAW INS.BIP.MARYLAND DISS.FEN.5/310MM (PART # PM438R) WAS USED DURING A PROCEDURE PERFORMED ON (B)(6) 2021. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE JAW BROKE. A BRANCH FELL INTO THE SITUS BUT COULD BE RECOVERED. THE COMPLAINT DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. ALTHOUGH REQUESTED, ADDITIONAL INFORMATION HAS NOT BEEN MADE AVAILABLE. THE MALFUNCTION IS FILED UNDER AAG REFERENCE XC (B)(4). INVOLVED COMPONENTS: PM450R - HANDLE FOR BIPOLAR INSTRUMENTS - LOT UNKNOWN. PM973R - INSULATED OUTER TUBE 5/5MM 310MM - LOT UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 12159283 ↗
• MalfunctionMay 11, 2021Fracture; Material Fragmentation; Fracture; Material Fragmentation

  INVOLVED COMPONENTS: PM600201 - METAL INNER TUBE 31CM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11806408 ↗
• MalfunctionNov 3, 2020Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH A MARYLAND FIXATION FORCEPS JAW INSERT. ACCORDING TO THE COMPLAINANT, THE CERAMIC PART OF THE JAW CAME OFF DURING SURGERY. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT HAS NOT YET BEEN RECEIVED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED. THE MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10782215 ↗
• MalfunctionNov 3, 2020Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH A MARYLAND FIXATION FORCEPS JAW INSERT. ACCORDING TO THE COMPLAINANT, THE CERAMIC PART OF THE JAW CAME OFF DURING SURGERY. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED. THE MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10781980 ↗
• MalfunctionNov 3, 2020Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH A MARYLAND FIXATION FORCEPS JAW INSERT. ACCORDING TO THE COMPLAINANT, THE CERAMIC PART OF THE JAW CAME OFF DURING SURGERY. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT HAS NOT YET BEEN RECEIVED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED. THE MALFUNCTION IS FILED UNDER AAG REFERENCE: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10781976 ↗