MAUDE Adverse Event Report: STRYKER TRAUMA KIEL FEMORAL NAIL PF, RIGHT T2 ALPHA FEMUR ANTEGRADE Ø10X380MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	23371038S
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/31/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided in a supplemental report.
Event or Problem Description
It was reported that, while using the t2 alpha pf nail, the surgeon put the nail down the canal and was using the recon locking construct and went to put the inferior wire in using the threaded recon wire and tried to adjust the trajectory anterior and the wire continuously missed the nail anterior.Because the wire would not go through the nail, the doctor was forced to use a different locking configuration which delayed the case.Surgical delay of 30 minutes without additional anesthesia to the patient.
Additional Manufacturer Narrative
This device is concomitant and did not contribute to the reported failure.If any additional information is provided indicating otherwise the record will be reopened and the investigation will be reworked.
Event or Problem Description
It was reported that, while using the t2 alpha pf nail, the surgeon put the nail down the canal and was using the recon locking construct and went to put the inferior wire in using the threaded recon wire and tried to adjust the trajectory anterior and the wire continuously missed the nail anterior.Because the wire would not go through the nail, the doctor was forced to use a different locking configuration which delayed the case.Surgical delay of 30 minutes without additional anesthesia to the patient.

• Brand Name: FEMORAL NAIL PF, RIGHT T2 ALPHA FEMUR ANTEGRADE Ø10X380MM
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32
• MDR Report Key: 8716504
• Report Number: 0009610622-2019-00502
• Device Sequence Number: 2021950
• Product Code: HSB
• UDI-Device Identifier: 07613327288704
• UDI-Public: 07613327288704
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K180436
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/01/2019

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: 23371038S
• Device Lot Number: K0E551C
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/31/2019
• Supplement Date Received by Manufacturer: 09/03/2019
• Initial Report FDA Received Date: 06/20/2019
• Supplement Report FDA Received Date: 10/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1