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

Model Number	3060-0085S
Medical Device Problem Codes	Device Damaged by Another Device (2915); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Nonunion/Delayed-union Bone Fracture (2369); Implant Pain (4561)
Date of Event	03/29/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
As reported: "broken gamma nail.Patient had a nonunion fracture.Patient had pain and required a revision procedure.The gamma nail was removed.".
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 0009610622-2022-00150
• Device Sequence Number: 4447442
• Product Code: HSB
• UDI-Device Identifier: 04546540374912
• UDI-Public: 04546540374912
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K032244
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/15/2022

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?: Yes
• Operator of Device: 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/29/2022
• Supplement Date Received by Manufacturer: 05/18/2022
• Initial Report FDA Received Date: 04/25/2022
• Supplement Report FDA Received Date: 06/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 64 YR
• Patient Sex: Female
• Patient Weight: 103 KG