MAUDE Adverse Event Report: STRYKER TRAUMA KIEL TARGET DEVICE T2 RECON; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	1806-3100
Medical Device Problem Code	Failure to Align (2522)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/11/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the following: "one wire broke and we miss the jig three times at the very end after many attempts throughout the surgery.The broken wire intra op that we could not remove, and also, a missing attempt to pass the wire through the nail x3." update : ((b)(6) 2021) the procedure was completed successfully.However, only one screw was placed on the femoral head, as the broken wire was on the trajectory of the second screw.The procedure was delayed by 42 minutes.
Additional Manufacturer Narrative
Upon completion of the investigation, additional information will be provided in a supplemental report.
Event or Problem Description
It was reported the following: "one wire broke and we miss the jig three times at the very end after many attempts throughout the surgery.The broken wire intra op that we could not remove, and also, a missing attempt to pass the wire through the nail x3.".Update : ((b)(6) 2021).The procedure was completed successfully.However, only one screw was placed on the femoral head, as the broken wire was on the trajectory of the second screw.The procedure was delayed by 42 minutes.
Additional Manufacturer Narrative
The reported event could not be confirmed, since the returned device is conforming to specifications and fully functional.The device inspection revealed the following: the received target device t2 recon.Shows traces of a frequent and intense use as evident by worn out surface around sleeve hole.However, a functional test was performed by using received devices (target device & k-wire sleeve) & sample devices (nail & k-wire).K-wire was able to pass through the sleeve hole to the nail without any misalignment hence, the reported event could not be confirmed.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.Based on the above investigation and available information, the exact root cause of the alleged misdrilling could not be confirmed as the device was found to be functionally ok.However, as a secondary observation, it was found that the sleeve hole was slightly worn out but it had no impact on the alleged event.If any further information is provided, the complaint report will be updated.

• Brand Name: TARGET DEVICE T2 RECON
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• 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: marilyne chaumont ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 12959443
• Report Number: 0009610622-2021-00809
• Device Sequence Number: 1855142
• Product Code: HSB
• UDI-Device Identifier: 04546540654939
• UDI-Public: 04546540654939
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K102992
• 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): 04/14/2022

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: 1806-3100
• Device Catalogue Number: 18063100
• Device Lot Number: KME904270
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/24/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/11/2021
• Supplement Date Received by Manufacturer: 03/19/2022
• Initial Report FDA Received Date: 12/08/2021
• Supplement Report FDA Received Date: 04/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/05/2012
• 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