MAUDE Adverse Event Report: STRYKER TRAUMA KIEL TISSUE PROTECTION SLEEVE, LONG IMN INSTRUMENTS Ø9MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	2351-0070
Medical Device Problem Codes	Break (1069); Fracture (1260); Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/06/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported event could be confirmed, since the device was returned and matches the alleged failure.We received the tissue protection sleeve for the inspection which revealed several scratches at the sleeve surface and material accumulation.The handle of the sleeve is broken which can be from forceful extraction.A functional inspection was performed with a sample adjusting device in which sleeve movement was as intended.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.Based on the investigation root cause can be attributed to user-related.If any additional information is provided, the investigation will be reassessed.
Event or Problem Description
As reported: "tissue protection sleeve long did not come off from adjusting device after screw insertion.It was damaged when forcibly pulled out.".

• Brand Name: TISSUE PROTECTION SLEEVE, LONG IMN INSTRUMENTS Ø9MM
• 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: 16864756
• Report Number: 0009610622-2023-00147
• Device Sequence Number: 17591511
• Product Code: LXH
• UDI-Device Identifier: 07613327368154
• UDI-Public: 07613327368154
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/03/2023

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: 2351-0070
• Device Catalogue Number: 23510070
• Device Lot Number: KP431182
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/07/2023
• Initial Report FDA Received Date: 05/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/21/2020
• 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