MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LONG NAIL KIT R1.5, TI, LEFT GAMMA3® Ø10X280MM X 130°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 35300280S

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Date 03/20/2019

Event Type  Injury  

Manufacturer Narrative

Upon completion of investigation, additional information will be provided in a supplemental report.

Event Description

It was reported that the patient underwent gamma3 u-lag screw surgery on (b)(6) 2019.After the surgery, the cutout of u-lag screw and the bending of u-blade were confirmed.Then gamma3 extraction and revision to tha was performed on (b)(6) 2019.

Event Description

It was reported that the patient underwent gamma3 u-lag screw surgery on (b)(6) 2019.After the surgery, the cutout of u-lag screw and the bending of u-blade were confirmed.Then gamma3 extraction and revision to tha was performed on (b)(6) 2019.

Manufacturer Narrative

This device is concomitant and did not contribute to the reported failure.If any additional information is provided indicating otherwise, the investigation will be updated accordingly.

• Brand Name: LONG NAIL KIT R1.5, TI, LEFT GAMMA3® Ø10X280MM 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
• MDR Report Key: 8483028
• MDR Text Key: 140919519
• Report Number: 0009610622-2019-00135
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 04546540375834
• UDI-Public: 04546540375834
• Combination Product (y/n): N
• PMA/PMN Number: K034002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 05/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 35300280S
• Device Lot Number: K0AECDA
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 89 YR
• Patient Weight: 48