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

Model Number	1320-0125
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/18/2020
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
Tube clip broke on the upper right side.So a piece is missing.Material weakened, and therefore, no longer usable.
Event or Problem Description
Tube clip broke on the upper right side.So a piece is missing.Material weakened and therefore no longer usable.
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 was found to be broken around the region from where the set screw is inserted.The breakage is clean and smooth.No sign of any significant deformation is visible; therefore, it can be said that the breakage was instantaneous possibly due to a sudden high force.The chipped off was not available for evaluation.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, sudden application of high load during previous surgery leading to instantaneous breakage and residual stress due to repeated cycles of reprocessing which renders the material weak over a period of time.Both the factors are user related.If any further information is provided, the complaint report will be updated.

• 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: 10996956
• Report Number: 0009610622-2020-00919
• Device Sequence Number: 690714
• Product Code: LXH
• UDI-Device Identifier: 04546540508003
• UDI-Public: 04546540508003
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/29/2021

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: K02ADED
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/23/2020
• Initial Date Received by Manufacturer: 11/18/2020
• Supplement Date Received by Manufacturer: 01/07/2021
• Initial Report FDA Received Date: 12/12/2020
• Supplement Report FDA Received Date: 01/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1