MAUDE Adverse Event Report: STRYKER TRAUMA KIEL CLOSED TUBE CLIP GAMMA3®; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	1320-0125
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/16/2022
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 instrument broke during use after completion of the surgery.
Additional Manufacturer Narrative
The reported event could be confirmed, since the product was returned for evaluation and matches the alleged failure mode.The device inspection revealed the following: the received device was found to be abruptly broken around the region from where the set screw is inserted.The chipped-off part was not available for evaluation.The device appears to be slightly worn off at the ends, most likely due to repeated usage & reprocessing cycles, the material may have disintegrated.The breakage area also indicates unwanted force applied most likely due to mishandling.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 material, manufacturing, or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.Based on the investigation, the root cause was attributed to a user-related issue.The failure was most likely caused by mishandling intra-operative and residual stress due to repeated cycles of reprocessing which renders the material weak over a period of time.If any further information is provided, the complaint report will be updated.
Event or Problem Description
The instrument broke during use after completion of the surgery.

• Brand Name: CLOSED TUBE CLIP GAMMA3®
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 14674819
• Report Number: 0009610622-2022-00245
• Device Sequence Number: 14666410
• Product Code: LXH
• UDI-Device Identifier: 04546540508003
• UDI-Public: 04546540508003
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/13/2022

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 Model Number: 1320-0125
• Device Catalogue Number: 13200125
• Device Lot Number: K0CDCA7
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/17/2022
• Supplement Date Received by Manufacturer: 09/20/2022
• Initial Report FDA Received Date: 06/13/2022
• Supplement Report FDA Received Date: 10/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown