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

Catalog Number 23371038S

Device Problem Difficult to Advance (2920)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/31/2019

Event Type  malfunction  

Manufacturer Narrative

Device will not be returned.If additional information becomes available, it will be provided in a supplemental report.

Event 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.

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 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
• Type of Device: 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
• MDR Text Key: 148826018
• Report Number: 0009610622-2019-00502
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 07613327288704
• UDI-Public: 07613327288704
• Combination Product (y/n): N
• PMA/PMN Number: K180436
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Catalogue Number: 23371038S
• Device Lot Number: K0E551C
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/31/2019
• Initial Date FDA Received: 06/20/2019
• Supplement Dates Manufacturer Received: 09/03/2019
• Supplement Dates FDA Received: 10/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1