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 Code	Device Difficult to Setup or Prepare (1487)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/31/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.Should additional information become available, it will be provided in a supplemental report.H3 other text : device disposition unknown.
Event or Problem Description
As reported: "a sleeve was inserted using a distal targeting device, but the sleeve did not reach the bone and could not be drilled and measured.The screw was inserted freehand.".
Event or Problem Description
As reported: "a sleeve was inserted using a distal targeting device, but the sleeve did not reach the bone and could not be drilled and measured.The screw was inserted freehand.".
Additional Manufacturer Narrative
The reported event could not be confirmed, from the available radiographs, and the device was not returned.From the available radiographs, a formal medical opinion was sought: the three screws that were used in the distal fixation holes have a good position and an adequate length.From the x-rays, the reported event of the distal targeting device did not influence the technical outcome of the surgery regarding the placement, position, and length of the three distal screws.A device inspection was not possible since the affected device was not returned and no other evidences were provided for investigation.A review of the device history was not possible because the lot number was not communicated.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.Indications of material, manufacturing, or design related problems were unable to be identified as the lot number was not communicated.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.If the device is returned, the investigation will be reassessed.

• 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: 16831678
• Report Number: 0009610622-2023-00138
• Device Sequence Number: 1855608
• 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: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/31/2023

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: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/31/2023
• Supplement Date Received by Manufacturer: 05/04/2023
• Initial Report FDA Received Date: 04/28/2023
• Supplement Report FDA Received Date: 05/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Male