MaxBraid Suture BroadBand Tape (Basic) 110046602Recalls & reported problems
Riverpoint Medical, LLC · Subscapularis Repair Suture Kit-Basic (Suture Kit - KIT703 is convenience kit containing HS Fiber sutures (K190817; K153307) and Drill Bit (HTW, 510k exempt)). · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00840277401373), received between Apr 14, 2023 and Apr 14, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Component Misassembled” (1 report).
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
Device problems
- Component Misassembled1
- Device Misassembled During Manufacturing /Shipping1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 14, 2023Device Misassembled During Manufacturing /Shipping; Component Misassembled; Device Misassembled During Manufacturing /Shipping; Component Misassembled
ACCORDING TO THE REPORTER, "THE SUBSCAP REPAIR KIT HAD X3 SHUTTLES AND X1 TAG SUTURE."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16742270 ↗
Other Suture Kit devices
- LSL HEALTHCARE 7554LSL Industries, LLC · Suture kit1 recall0 reports
- Medline Industries, Inc. P903933BMedline Industries, Inc. · Suture kit1 recall0 reports
- Lock-Stitch™ Procedure Kit CM9500Cayenne Medical, Inc. · Suture Kit2 reports
- McKesson 25-2748Mckesson Medical-Surgical Inc. · Suture Kit2 reports
- Medical Action Industries 79350Medical Action Industries Inc. · Suture kit1 report
- Syneture US1716Covidien LP · Suture kit1 report
- Syneture US1560Covidien LP · Suture kit1 report
- McKesson 25-2691Mckesson Medical-Surgical Inc. · Suture Kit1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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