MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LONG NAIL KIT R1.5, TI, RIGHT GAMMA3 10X260MM X 125; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	3425-0260S
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	08/20/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
Event or Problem Description
As reported: "on (b)(6) 2020, the patient underwent the operation for fracture of the proximal femur.On (b)(6) 2020, the patient underwent revision surgery due to breakage of the implant.It is uncertain when the implant broke." the additional information was received: "trochanteric fracture reverse type (reverse oblique fracture under lug screw)nail was used in the operation of the second revision, and the progress is good.A gap remained in the fractured part in a difficult reduction case it is believed that the implant is likely to have broken [.]." the additional information on patient's history was received: "the patient had history of left tha, lumbar compression fracture (conservative therapy).".
Event or Problem Description
As reported: "on (b)(6) 2020, the patient underwent the operation for fracture of the proximal femur.On (b)(6) 2020, the patient underwent revision surgery due to breakage of the implant.It is uncertain when the implant broke." the additional information was received: "trochanteric fracture reverse type (reverse oblique fracture under lug screw)nail was used in the operation of the second revision, and the progress is good.A gap remained in the fractured part in a difficult reduction caseit is believed that the implant is likely to have broken [.]." the additional information on patient's history was received: "the patient had history of left tha, lumbar compression fracture (conservative therapy).".
Additional Manufacturer Narrative
The reported event could be confirmed, since the product was returned for evaluation and matches the alleged failure mode.The device inspection revealed the following: visual inspection confirms the breakage of nail.The drill mark at posterior-lateral web (entry point) indicates the mis-drilling.Also, the diagonally opposite drill marks on hole surface indicate the misalignment of drill with hole axis.The rest lines on broken surface indicate the fatigue fracture of nail.The fracture was initiated from posterior-lateral web and passed until posterior-medial web.The rough fracture surface at anterior-medial web indicates final fracture of nail.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.The operative technique instructs user that: ¿in the event the nail is damaged during lag screw reaming, the fatigue strength of the implant may be reduced, which may cause nail to fracture.¿ based on investigation, the root cause was attributed to a user related issue.The failure was caused by the compromised fatigue strength of device due to mis-drilling.If any further information is provided, the complaint report will be updated.

• Brand Name: LONG NAIL KIT R1.5, TI, RIGHT GAMMA3 10X260MM X 125
• 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
• MDR Report Key: 10708428
• Report Number: 0009610622-2020-00572
• Device Sequence Number: 2960079
• Product Code: HSB
• UDI-Device Identifier: 04546540375308
• UDI-Public: 04546540375308
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K034002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/29/2020

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: 10/31/2023
• Device Model Number: 3425-0260S
• Device Catalogue Number: 34250260S
• Device Lot Number: K098471
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2020
• Initial Date Received by Manufacturer: 09/25/2020
• Supplement Date Received by Manufacturer: 12/03/2020
• Initial Report FDA Received Date: 10/20/2020
• Supplement Report FDA Received Date: 12/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR
• Patient Weight: 54