MAUDE Adverse Event Report: STRYKER TRAUMA KIEL TARGETING ARM T2 PROX. HUM.; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	1806-2035
Medical Device Problem Code	Failure to Align (2522)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/21/2022
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
It was reported a missed target was discovered when checking the target accuracy before nail insertion.Spare instruments were arranged and used to complete the procedure.
Additional Manufacturer Narrative
The reported event could be confirmed, since physical evaluation revealed a targeting inaccuracy.The device inspection revealed the following: the received targeter shows traces of a frequent and intense use.The printings on the target device were turned from white to fawn; an indication for a high level of sterilization cycles.Detailed inspection revealed that the distal shaft is slightly twisted in itself.Simulation of a pre-functional check revealed that the function of the item is no longer given due to damage verified.The reported targeting inaccuracy was reproducible with sample counterparts.Based on investigation and since nothing was reported after the last usage in a surgical procedure and furthermore, during assembling before sterilization in the current case, the root cause is rather related to an inadequate reprocessing.Known from similar cases the bent shaft was caused by a result of bending forces during reprocessing, most likely caused by loaded instruments on the targeter.Nevertheless, as instructed per ifu accuracy in guidance needs to be checked prior to the surgical procedure.If simulation of a pre-operative check would have been performed before the surgical procedure and after reprocessing performed it would have been noticed at this time as it¿s clear evident.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 case substantive information will become available in future that suggests otherwise we reserve the right to reopen the case.
Event or Problem Description
It was reported that a missed target was discovered when checking the target accuracy before nail insertion.Spare instruments were arranged and used to complete the procedure but the surgery was interrupted for almost two and a half hours and patient required additional anesthesia.

• Brand Name: TARGETING ARM T2 PROX. HUM.
• 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: 13552501
• Report Number: 0009610622-2022-00056
• Device Sequence Number: 5236267
• Product Code: LXH
• UDI-Device Identifier: 04546540379658
• UDI-Public: 04546540379658
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Report Date (Section B): 06/30/2022

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: 1806-2035
• Device Catalogue Number: 18062035
• Device Lot Number: KHI005117
• 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: 01/21/2022
• Supplement Date Received by Manufacturer: 06/03/2022
• Initial Report FDA Received Date: 02/17/2022
• Supplement Report FDA Received Date: 06/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/06/2019
• 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 Age: 70 YR
• Patient Sex: Female