MAUDE Adverse Event Report: STRYKER GMBH GUIDE WIRE WITH RULER TUBE IMN INSTRUMENTS Ø3X1000 MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	23513100S
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
As reported: "a complaint was reported this morning with respect to the guide wire ruler tubes.During usage, the surgeon reports that the metal component on the bottom end of the guide wire ruler tube was detached from the device intraoperatively, leaving the metal component free floating in the incision site around the knee.Used new guide wire measuring tub and the silver cap debonded.No replacement device was used.The ring loosened during the removal of the measuring tube through the metal 8-11 alpha tibia suprapatellar sleeve.I don¿t recall the ring getting caught on any bone.The ring was removed during the surgery.".
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: "a complaint was reported this morning with respect to the guide wire ruler tubes.During usage, the surgeon reports that the metal component on the bottom end of the guide wire ruler tube was detached from the device intraoperatively, leaving the metal component free floating in the incision site around the knee.Used new guide wire measuring tub and the silver cap debonded.No replacement device was used.The ring loosened during the removal of the measuring tube through the metal 8-11 alpha tibia suprapatellar sleeve.I don¿t recall the ring getting caught on any bone.The ring was removed during the surgery.".
Additional Manufacturer Narrative
The reported event could be confirmed on provided x-ray.The device inspection revealed the following: from the guide wire with ruler tube imn instruments 03x1000 mm only the transparent ruler tube was returned.The item had initially been separated in 2 parts in order to have it thoroughly cleaned inside.Some centimeters in front of the metal ring a slight bent was apparent in the tube.The meal ring was not in flush position on the tube and a very slight deformation was found at the edge of the flute.The ring did not fall off from the tube neither by shaking nor by its own weight; although it could easily be pulled off by hand.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.In the case presented a patient had been treated using above ruler tube.It was reported that during usage, the metal component on the bottom end of the guide wire ruler tube was detached from the device intraoperatively, the ring loosened during the removal of the measuring tube through the metal, suprapatellar sleeve.The ring was removed during the surgery.Investigation revealed the returned product being within specifications and functional.Although denied it could only be suggested that the ring hooked up within the tissue or supporting instruments - but could not be confirmed.With available information a real root cause could not be determined.With available information a product deficiency was not verified.
Additional Manufacturer Narrative
Please note the correction to b1, h1 and h6 health impact code.The report has been downgraded from si to reportable malfunction to be consistent with actual and potential severity.
Event or Problem Description
As reported: "a complaint was reported this morning with respect to the guide wire ruler tubes.During usage, the surgeon reports that the metal component on the bottom end of the guide wire ruler tube was detached from the device intraoperatively, leaving the metal component free floating in the incision site around the knee.Used new guide wire measuring tub and the silver cap debonded.No replacement device was used.The ring loosened during the removal of the measuring tube through the metal 8-11 alpha tibia suprapatellar sleeve.I don¿t recall the ring getting caught on any bone.The ring was removed during the surgery.".

• Brand Name: GUIDE WIRE WITH RULER TUBE IMN INSTRUMENTS Ø3X1000 MM
• 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: 18674984
• Report Number: 0009610622-2024-00059
• Device Sequence Number: 20375158
• Product Code: LXH
• UDI-Device Identifier: 07613327361803
• UDI-Public: 07613327361803
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/12/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 23513100S
• Device Lot Number: KU164770
• 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: 02/01/2024
• Supplement Date Received by Manufacturer: 05/17/2024; 03/07/2025
• Initial Report FDA Received Date: 02/09/2024
• Supplement Report FDA Received Date: 06/13/2024; 03/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/15/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 19 YR
• Patient Sex: Male