MAUDE Adverse Event Report: STRYKER TRAUMA KIEL TARGETING ARM FEMUR PF T2 ALPHA FEMUR ANTEGRADE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	2353-3503
Medical Device Problem Code	Failure to Align (2522)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/11/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon completion of the investigation any additional information will be communicated in a supplemental report.
Event or Problem Description
It was reported that when setting initial depth and version with the mil fal the lag screw k-wire, it kept missing the nail posterior and hit once proximal.This resulted in a 1-1.5 hour surgical delay.Pre-testing confirmation of recon lag screw targeting at a prior date and the device worked as expected.Another surgeon scrubbed in and assisted the lost reduction of the fracture and helped complete the case.
Additional Manufacturer Narrative
The reported event could not be confirmed, since the returned device is conforming to specifications and fully functional.A simulation of a pre-surgical function check revealed function is given as intended.According to event description ¿not prior to nail insertion but pre-testing confirmation of recon lag screw targeting was performed at a prior date and it worked fine¿.Based on above facts the case is rather related to a sub-optimal intraoperative procedure and has to be classified as user related.A review of the inspection records for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.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 when setting initial depth and version with the mil fal the lag screw k-wire, it kept missing the nail posterior and hit once proximal.This resulted in a 1-1.5 hour surgical delay.Pre-testing confirmation of recon lag screw targeting at a prior date and the device worked as expected.Another surgeon scrubbed in and assisted the lost reduction of the fracture and helped complete the case.

• Brand Name: TARGETING ARM FEMUR PF T2 ALPHA FEMUR ANTEGRADE
• 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: 12447255
• Report Number: 0009610622-2021-00683
• Device Sequence Number: 19848729
• Product Code: HSB
• UDI-Device Identifier: 07613327338645
• UDI-Public: 07613327338645
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K191271
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/21/2021

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: 2353-3503
• Device Catalogue Number: 23533503
• Device Lot Number: KP408600
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/11/2021
• Supplement Date Received by Manufacturer: 11/24/2021
• Initial Report FDA Received Date: 09/09/2021
• Supplement Report FDA Received Date: 12/21/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/05/2018
• 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 Age: 57 YR
• Patient Sex: Unknown