MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LONG NAIL KIT R1.5, TI, RIGHT GAMMA3® Ø11X380MM X 130°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	3430-1380S
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Implant Pain (4561)
Date of Event	10/11/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the patient had a broken nail.They presented with pain.Revision surgery was required.
Additional Manufacturer Narrative
Upon completion of the investigation any additional information will be communicated in a supplemental report.
Event or Problem Description
It was reported the patient had a broken nail.They presented with pain.Revision surgery was required.
Additional Manufacturer Narrative
The reported event could be confirmed, since the device was returned and shows a breakage at the level of the lag screw hole.The device inspection shows that no significant traces of mis-drilling can be noticed on the inside surface of the screw hole.An analysis of the surface breakage of the bridges shows some shiny surfaces on the posterior bridge, which are a clear indicator of fatigue fractures.Indeed, the nail most probably broke at the level of one of the bridges first, resulting in the two parts of the nail (proximal and distal) rubbing against each other, and creating the shiny surface that can be seen in the picture.The analysis of the anterior bridge confirms this failure pattern (fatigue), since clear rest lines, which correspond to the progressive propagation of the fracture, can be seen.Based on investigation, the root cause was attributed to a user related issue.The failure was caused by a fatigue fracture following an extended mechanical loading of the implant.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If more information is provided, the case will be reassessed.

• Brand Name: LONG NAIL KIT R1.5, TI, RIGHT GAMMA3® Ø11X380MM X 130°
• 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: sharon rivas ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 12759446
• Report Number: 0009610622-2021-00774
• Device Sequence Number: 3333070
• Product Code: HSB
• UDI-Device Identifier: 07613252273998
• UDI-Public: 07613252273998
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K034002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/10/2022

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 Expiration Date: 09/30/2025
• Device Model Number: 3430-1380S
• Device Catalogue Number: 34301380S
• Device Lot Number: K0BED03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/11/2021
• Supplement Date Received by Manufacturer: 01/14/2022
• Initial Report FDA Received Date: 11/07/2021
• Supplement Report FDA Received Date: 02/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/08/2020
• 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; Hospitalization
• Patient Age: 77 YR
• Patient Sex: Female
• Patient Weight: 63 KG