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

Catalog Number	23510070
Medical Device Problem Codes	Break (1069); Fracture (1260); Device Difficult to Setup or Prepare (1487); Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/08/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
As reported: "when it was performed the calibration before nail insertion, the sleeve was too hard to insert to the most proximal hole of the device.And the surgeon gave up screw inserting to that hole.The other proximal holes of the device were also checked and it was felt harder than usual.The nail was inserted as it was and inserted a screw into the proximal oval hole, but the sleeve would not be removed from the device.The surgeon pulled on the sleeve and the sleeve broke off.".
Event or Problem Description
As reported: "when it was performed the calibration before nail insertion, the sleeve was too hard to insert to the most proximal hole of the device.And the surgeon gave up screw inserting to that hole.The other proximal holes of the device were also checked and it was felt harder than usual.The nail was inserted as it was and inserted a screw into the proximal oval hole, but the sleeve would not be removed from the device.The surgeon pulled on the sleeve and the sleeve broke off.".
Additional Manufacturer Narrative
The reported event could be confirmed based on the inspection performed.The device inspection revealed the following: the identification of the returned sleeve was confirmed based on the catalog # and lot # marked.The knob of the tip was returned detached from the sleeve and fractured, as a result of the reported forced disassembling.Multiple scratches were observed on the device's shaft, which are a result of friction with targeting arm during previous use, but also during the reported forced assembling and disassembling.Due to the wear, local material thickening could be observed on some parts.The sleeve was tested with the returned targeting arm.As reported, the insertion of the sleeve could not be properly performed in any of the holes.Afterwards, the targeting arm was tested with a fully functional sleeve, where the assembling and disassembling worked without any issue.This gives indication that the targeting arm is fully functional and that the impairment observed is solely related to the sleeve.Dimensional inspection gives indication that the sleeve was manufactured according to specification and that the local material thickening was indeed a result of wear.Based on investigation, the root cause was attributed to an user related issue.The impaired assembly was most probably caused by the local material thickening observed on parts on the sleeve, which is a result of friction with the targeting arm but of probable careless handling when performing the assembling during previous use.Furthermore, the fact that issue was noticed during the procedure gives indication that hcp failed to properly inspect the sleeve and the assembly of the instruments, as advised.As a reminder, the instructions for use clearly state: ¿ always treat the instrument carefully to avoid surface damage or alterations to the geometry.Before the surgical procedure, ensure that all components prepared for the procedure function correctly with each other.¿.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.

• 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: 19246940
• Report Number: 0009610622-2024-00182
• Device Sequence Number: 17972100
• 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: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/06/2024

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?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/08/2024
• Supplement Date Received by Manufacturer: 05/23/2024
• Initial Report FDA Received Date: 05/06/2024
• Supplement Report FDA Received Date: 06/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/17/2020
• 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: 22 YR
• Patient Sex: Male