MAUDE Adverse Event Report: STRYKER GMBH TARGETING ARM TNS T2 TIBIA; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	18061001
Medical Device Problem Code	Failure to Align (2522)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/30/2023
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: "misdrillings occured.The surgery was successfully completed by performing freehand locking.".
Event or Problem Description
As reported: "misdrillings occured.The surgery was successfully completed by performing freehand locking.".
Additional Manufacturer Narrative
The reported event could be confirmed, since the returned device is not functional as required anymore.The device inspection revealed the following: the targeting arm was returned for evaluation.The visual inspection of the nail adapter interface has shown that the surface is strongly worn, which indicates that the device was often and intense used.The glass-fiber reinforced part of the targeting arm is in a good condition with just slight wear marks, the markings are good readable.A functional test was conducted, but after the nail adapter was attached to the targeting arm it was directly noticed that the adapter is slightly movable at the end.The movement was caused by some play between the metal locking mechanism and the glass-fiber reinforced part at the targeting arm.The detected movement of the nail adapter has clearly an influence on the aiming accuracy of the system and the complaint can therefore be rated as confirmed.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 investigation, the root cause was attributed to a use related issue.The event was caused by a combination between high torsional loads during use and wear over the years at this in the year 2012 manufactured device.In general following statements of the instructions for use can be pointed out in relation to this complaint: ¿ before every operation, ensure that all devices to be used during the operation function correctly with each other.During the procedure, repeatedly check that the connections between the instruments or between implants and instruments required for the precise positioning and fixing are secure." if more information is provided, the case will be reassessed.

• Brand Name: TARGETING ARM TNS T2 TIBIA
• 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: 18357375
• Report Number: 0009610622-2023-00458
• Device Sequence Number: 17841146
• Product Code: LXH
• UDI-Device Identifier: 04546540196521
• UDI-Public: 04546540196521
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/21/2024

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: 18061001
• Device Lot Number: KHI114669
• 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: 11/30/2023
• Supplement Date Received by Manufacturer: 02/29/2024
• Initial Report FDA Received Date: 12/19/2023
• Supplement Report FDA Received Date: 03/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/12/2012
• 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