MAUDE Adverse Event Report: STRYKER TRAUMA KIEL FEMORAL NAIL, A/R T2 FEMUR 9X300 MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	1825-0930S
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	04/06/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Upon completion of the investigation any additional information will be reported in a supplemental report.
Event or Problem Description
The following was reported: nail fracture in the proximal area of the screw connection.
Additional Manufacturer Narrative
D4 - lot number corrected the reported event could be confirmed, since provided x-ray images show a broken nail.The device inspection revealed the following: the received nail is completely broken in the webs of the most distal of the proximal drill holes for the locking screws.Due to the nature of the returned device, a functional inspection was not possible.Dimensional inspection [with exception of the damaged areas] revealed the nail dimensions to be as defined per drawing.We received x-ray images which were forwarded to a medical expert for a statement [excerpts]: ¿the nail is so long that it comes into contact with the inserted hip tep.There is a fracture dehiscence of at least 2-3mm.Due to the static locking and the contact with the tep, no dynamization was possible and a consequent implant failure occurred at the weakest point of the nail.¿ based on investigation, the root cause was attributed to a user related issue.The failure was caused by ¿kissing implants¿, which was confirmed by a medical expert.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.As a collateral finding the label copy sheet revealed that the implant was manufactured in 2013 and thus, an implant was used where the shelf life [2018-06] was already exceeded for a longer time at the time of implantation [march 2021].It could not be excluded that this is a contributing factor as well.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.
Event or Problem Description
The following was reported: nail fracture in the proximal area of the screw connection.

• Brand Name: FEMORAL NAIL, A/R T2 FEMUR 9X300 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
• MDR Report Key: 11756515
• Report Number: 0009610622-2021-00461
• Device Sequence Number: 14229263
• Product Code: HSB
• UDI-Device Identifier: 04546540199355
• UDI-Public: 04546540199355
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K010801
• 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): 07/28/2021

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: 06/30/2018
• Device Model Number: 1825-0930S
• Device Catalogue Number: 18250930S
• Device Lot Number: K03B99E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2021
• Initial Date Received by Manufacturer: 04/07/2021
• Supplement Date Received by Manufacturer: 07/20/2021
• Initial Report FDA Received Date: 04/30/2021
• Supplement Report FDA Received Date: 07/28/2021
• 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: 53 YR