MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LAG SCREW, TI GAMMA3® Ø10.5X85MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number 3060-0085S

Device Problems Device Damaged by Another Device (2915); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Non-union Bone Fracture (2369); Implant Pain (4561)

Event Date 03/29/2022

Event Type  Injury  

Manufacturer Narrative

Once the investigation has been completed any additional information will be reported in a supplemental report.

Event Description

As reported: "broken gamma nail.Patient had a nonunion fracture.Patient had pain and required a revision procedure.The gamma nail was removed.".

Manufacturer Narrative

This device is concomitant, the returned device was visually inspected and did not contribute to the reported failure.Therefore, this complaint is closed without further investigation.If any additional information is provided indicating otherwise the record will be reopened and the investigation will be reworked.

Event Description

As reported: "broken gamma nail.Patient had a nonunion fracture.Patient had pain and required a revision procedure.The gamma nail was removed.".

• Brand Name: LAG SCREW, TI GAMMA3® Ø10.5X85MM
• 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: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 14193749
• MDR Text Key: 289975875
• Report Number: 0009610622-2022-00150
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 04546540374912
• UDI-Public: 04546540374912
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K032244
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 3060-0085S
• Device Catalogue Number: 30600085S
• Device Lot Number: K0B627C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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): Required Intervention
• Patient Age: 64 YR
• Patient Sex: Female
• Patient Weight: 103 KG