MAUDE Adverse Event Report: STRYKER TRAUMA KIEL SCREW GAUGE, SHORT T2 TIBIA; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	18060330
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/17/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
The hospital reported the following event : "measurer short broken, unusable.".
Additional Manufacturer Narrative
The reported event that screw gauge, short t2 tibia was alleged of issue (instruments - broken, deformed, worn or scratched) could be confirmed, since the device was returned for evaluation and matches the alleged failure mode.The device inspection revealed the following: the screw gauge received showed traces of an intense and frequent use.The sleeve of the screw gauge was found to be bend and broken.The bend in the sleeve indicate application of excessive force (overload) during use or sterilization.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of manufacturing or design related problems were found during the investigation.The device had been in use for 14 years (manufactured 2005), so we can safely say that they had fulfilled their tasks in former surgeries as intended.In conjunction with the signs of intense use, it could be safely assumed that the device exceeded its life time.Based on investigation, the root cause was attributed to a user related issue.The failure was caused due to inadequate handling by the user combined with normal wear and tear of the device.Stryker trauma & extremities typically does not specify the maximum number of uses appropriate for re-usable medical devices.The useful life of these devices depends on many factors including the method and duration of each use, and the handling between uses.Careful inspection and functional test of the device before use is the best method of determining the end of serviceable life for the medical device.A review of the labeling did not indicate any abnormalities.If any further information is provided, the complaint report will be updated.
Event or Problem Description
The hospital reported the following event: "measurer short broken, unusable." the additional information received indicate that the event happened during an intervention, removal of a t2 nail.There was no delay and no impact on the patient.

• Brand Name: SCREW GAUGE, SHORT T2 TIBIA
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32
• MDR Report Key: 8243900
• Report Number: 0009610622-2019-00035
• Device Sequence Number: 1439746
• Product Code: LXH
• UDI-Device Identifier: 04546540196415
• UDI-Public: 04546540196415
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 03/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 18060330
• Device Lot Number: K756095
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2019
• Initial Date Received by Manufacturer: 12/17/2018
• Supplement Date Received by Manufacturer: 03/11/2019
• Initial Report FDA Received Date: 01/14/2019
• Supplement Report FDA Received Date: 03/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other