MAUDE Adverse Event Report: STRYKER TRAUMA KIEL TROCHANTERIC NAIL KIT, TI GAMMA3 12X170MM X 130; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 31302170S

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Bone Fracture(s) (1870)

Event Date 08/24/2021

Event Type  Injury  

Manufacturer Narrative

The device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Nail remains implanted.

Event Description

It was reported that during insertion of the nail, a fracture occurred at another site.It was determined the surgery could be continued and the procedure was completed as planned.No treatment was performed for the subtrochanteric fracture.

• Brand Name: TROCHANTERIC NAIL KIT, TI GAMMA3 12X170MM X 130
• Type of Device: 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: kristen canter ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 12478236
• MDR Text Key: 271665425
• Report Number: 0009610622-2021-00691
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 04546540375148
• UDI-Public: 04546540375148
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K034002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 31302170S
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/24/2021
• Initial Date FDA Received: 09/15/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 99 YR