NA 690.109Recalls & reported problems
Synthes GmbH · TEN SYSTEM GRAPHIC CASE · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982251954), received between May 14, 2018 and May 14, 2018 — classified as 1 injury.
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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- No Code Available1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMay 14, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THE REAMER/IRRIGATOR/ASPIRATOR (RIA) INSTRUMENT SET AND THE TITANIUM ELASTIC NAIL (TEN) SYSTEM SET WERE NOT DELIVERED TO STERILE PROCESSING AND, THEREFORE, NOT STERILIZED FOR USE ON (B)(6) 2018. PATIENT WAS IN PRE-OPERATIVE STAGING WHEN THE ISSUE WAS NOTED. SURGERY WAS CANCELLED AND PATIENT WAS NOTIFIED TO RETURN HOME. SURGERY WAS RESCHEDULED FOR THE FOLLOWING DAY, (B)(6) 2018. THIS REPORT IS FOR ONE (1) TITANIUM ELASTIC NAIL SYSTEM SET. THIS IS REPORT 2 OF 2 FOR (B)(4).
Patient problems: No Code Available
MAUDE report 7510682 ↗
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- ATTUNE 2545-01-704Depuy (Ireland) · TRAY, SURGICAL, INSTRUMENT57 reports
- n.a. 39501XKarl Storz GmbH & Co. KG · TRAY, SURGICAL, INSTRUMENT1 recall0 reports
- Medical Action Industries 6810Medical Action Industries Inc. · TRAY, SURGICAL, INSTRUMENT1 recall0 reports
- n.a. 39501BECKarl Storz GmbH & Co. KG · TRAY, SURGICAL, INSTRUMENT1 recall0 reports
- n.a. 39501XKKarl Storz GmbH & Co. KG · TRAY, SURGICAL, INSTRUMENT1 recall0 reports
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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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