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

Model Number	1320-0125S
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)
Date of Event	06/23/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
Event or Problem Description
The customer reports that the device has broken.The missing piece could not be found after the surgery.A piece of the device could be inside the patient's body.
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 device received is broken from around the region from where the set screw is inserted.A crack is visible propagating from the free end.Also, signs of intense usage are also visible.It was suspected that some material chipped of from the device, but it could not be confirmed.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.A review of the labeling did not indicate any abnormalities.Based on the above investigation and the pattern of breakage the failure is attributed to a combination of two factors, forces developed due to intense usage during insertion of set screw and residual stress due to repeated cycles of reprocessing which renders the material weak over a period.Both of the factors are user related.The ifu states: ¿ changes in mechanical, physical or chemical characteristics introduced under conditions of repeated use, cleaning and re-sterilization may compromise the integrity of the design and/or materials leading to diminished safety, performance and/or compliance with relevant specifications.Note: stryker trauma & extremities typically does not specify the maximum number of uses appropriate for reusable 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.¿ if any further information is provided, the complaint report will be updated.
Event or Problem Description
The customer reports that the device has broken.The missing piece could not be found after the surgery.A piece of the device could be inside the patient's body.

• 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
• MDR Report Key: 10290917
• Report Number: 0009610622-2020-00329
• Device Sequence Number: 1073716
• Product Code: LXH
• UDI-Device Identifier: 07613154570386
• UDI-Public: 07613154570386
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/15/2020

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: 1320-0125S
• Device Catalogue Number: 13200125
• Device Lot Number: K0C8009
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2020
• Initial Date Received by Manufacturer: 06/23/2020
• Supplement Date Received by Manufacturer: 08/20/2020
• Initial Report FDA Received Date: 07/17/2020
• Supplement Report FDA Received Date: 09/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1