MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LAG SCREW, RECON T2 RECON Ø6.5X115 MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	1897-6115S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	03/16/2022
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
Patient came in with pain and the nail was broken at the bottom juncture of lower recon screw.The surgeon removed the t2 alpha retrograde nail and replaced it with a gamma nail.Surgery was successful.
Event or Problem Description
Patient came in with pain and the nail was broken at the bottom juncture of lower recon screw.The surgeon removed the t2 alpha retrograde nail and replaced it with a gamma nail.Surgery was successful.
Additional Manufacturer Narrative
Please note the correction that this device is concomitant and did not contribute to the reported failure.The event was initially misunderstood and the screws were also handled as broken devices but they should been handled as concomitant devices.

• Brand Name: LAG SCREW, RECON T2 RECON Ø6.5X115 MM
• 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: 14054151
• Report Number: 0009610622-2022-00126
• Device Sequence Number: 4961517
• Product Code: HSB
• UDI-Device Identifier: 04546540384836
• UDI-Public: 04546540384836
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K032898
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/20/2022

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 1897-6115S
• Device Catalogue Number: 18976115S
• Device Lot Number: K070781
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/16/2022
• Supplement Date Received by Manufacturer: 05/24/2022
• Initial Report FDA Received Date: 04/08/2022
• Supplement Report FDA Received Date: 06/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 41 YR
• Patient Sex: Male