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

Model Number	1806-3100
Medical Device Problem Codes	Failure to Align (2522); Material Twisted/Bent (2981)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	01/16/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a case the targeting arm did not hit the hole in the nail upon first attempt and the surgeon had to retry several times and drill unnecessary holes resulting in a surgical delay of approx 30 min.The case was completed successfully; no hardware was left in the patient and a second surgery is not required.It was later observed that the device was bent.
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Additional Manufacturer Narrative
Please note the correction to d9/h3 as the device was not returned for evaluation.The reported event could not be confirmed, since the device was not returned for evaluation and no other evidence was provided.Pre-supposing that positioning accuracy for drilling was confirmed by pre-operative check performed, which is required per ifu, it was concluded that the event was mainly based in the medical procedure.Based on details available ¿it was later observed that the device was bent¿ and due to the fact, nothing was reported after the last reprocessing and/or during the time of required functional check prior surgery and thus, it could not be excluded that the alleged event is most likely caused due to a sub-optimal intraoperative procedure and has to be classified as user-customer-user error.A review of the device history was not possible because the lot number was not communicated.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.H3 other text : device disposition unknown.
Event or Problem Description
It was reported that during a case the targeting arm did not hit the hole in the nail upon first attempt and the surgeon had to retry several times and drill unnecessary holes resulting in a surgical delay of approx 30 min.The case was completed successfully; no hardware was left in the patient and a second surgery is not required.It was later observed that the device was bent.

• 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: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 16417739
• Report Number: 0009610622-2023-00051
• Device Sequence Number: 20178070
• Product Code: HSB
• UDI-Device Identifier: 04546540654939
• UDI-Public: 04546540654939
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 05/12/2023

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: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/30/2023
• Supplement Date Received by Manufacturer: 04/18/2023
• Initial Report FDA Received Date: 02/22/2023
• Supplement Report FDA Received Date: 05/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 Sex: Unknown