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

Catalog Number	23510070
Medical Device Problem Codes	Device Difficult to Setup or Prepare (1487); Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/08/2024
Type of Reportable Event	Malfunction
Event or Problem Description
As reported: "the sleeve did not pass through the oblique hole in the targeting arm femur gt.The button was pushed but the sleeve did not go through.Hammering the sleeve while pressing the button only advanced it a little.When pulling out the sleeve, it could not be manually pulled out; the sleeve had to be clamped with pliers and beaten out with a hammer.Finally, the screw could not be inserted into the hole where it should be inserted".
Additional Manufacturer Narrative
Upon completion of the investigation, additional information will be provided in a supplemental report.
Additional Manufacturer Narrative
The reported event could not be confirmed the returned device is conforming to specifications and fully functional.The device inspection revealed the following: the sleeve shows several marks and signs of wear.However, there are only signs of normal usage over time, and there is no visible and significant damage or deformation that could have contributed to the event.The side of the plastic knob is heavily damaged and deformed.However, since the knob does not pass through the target device holes, this could not have contributed to the reported event.This damage was most probably caused by the user during the several attempts to push and pull the sleeve through the hole using a hammer.The sleeve could be inserted trough the most proximal hole.However, it did not pass easily through the hole as intended.Efforts were necessary to insert and remove the sleeve from the hole; abnormal resistance was felt.It is worth noting the sleeve was able to be inserted through all the other holes, left and right.The sleeve was easily inserted when pushing the button and was also easily pulled out.The returned sleeve was also tested with a sample targeting arm (b)(6), fully functional.The sleeve was easily inserted into the most proximal hole when pushing the button and was also easily pulled out.There was no abnormal resistance of any kind.In addition, relevant dimensions were measured, confirming the sleeve was manufactured according to specifications.Therefore, it can be confirmed the sleeve is fully functional and did not contribute to the reported failure; only the targeting arm did.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.If more information is provided, the case will be reassessed.
Event or Problem Description
As reported: "the sleeve did not pass through the oblique hole in the targeting arm femur gt.The button was pushed but the sleeve did not go through.Hammering the sleeve while pressing the button only advanced it a little.When pulling out the sleeve, it could not be manually pulled out; the sleeve had to be clamped with pliers and beaten out with a hammer.Finally, the screw could not be inserted into the hole where it should be inserted.".

• Brand Name: TISSUE PROTECTION SLEEVE, LONG IMN INSTRUMENTS Ø9MM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• 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: 20858865
• Report Number: 0009610622-2024-00943
• Device Sequence Number: 4058501
• Product Code: LXH
• UDI-Device Identifier: 07613327368154
• UDI-Public: (01)07613327368154(11)200317(10)K04EE28
• 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): 03/03/2025

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 Catalogue Number: 23510070
• Device Lot Number: KP431181
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/08/2024
• Supplement Date Received by Manufacturer: 02/04/2025
• Initial Report FDA Received Date: 12/05/2024
• Supplement Report FDA Received Date: 03/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/12/2020
• 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 Age: 73 YR
• Patient Sex: Male
• Patient Weight: 63 KG