MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LONG NAIL KIT R1.5, TI, RIGHT GAMMA3 11X380MM X 125 ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number 3425-1380S

Device Problem Fracture (1260)

Patient Problems Fall (1848); Failure of Implant (1924); Implant Pain (4561)

Event Date 11/18/2020

Event Type  Injury  

Manufacturer Narrative

Upon completion of investigation, additional information will be provided in a supplemental report.

Event Description

The customer reported that the gamma 3 femoral nail (right) broke at proximal end in-situ, just above lag screw hole. The nail has subsequently sunk and caused the distal locking screws to snap. This nail has been successfully extracted and revised.

Manufacturer Narrative

Please note corrections to b1 and h6 (clinical signs code and conclusion code).

Event Description

The customer reported that the gamma 3 femoral nail (right) broke at proximal end in-situ, just above lag screw hole. The nail has subsequently sunk and caused the distal locking screws to snap. This nail has been successfully extracted and revised.

Event Description

The customer reported that the gamma 3 femoral nail (right) broke at proximal end in-situ, just above lag screw hole. The nail has subsequently sunk and caused the distal locking screws to snap. This nail has been successfully extracted and revised.

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: the received nail is completely broken in the webs of the proximal lag screw hole. The appearance of the breakage surface of the posterior web suggests that the nail breakage had its origin in this area. The fracture pattern resembles a brittle overload fracture, evident by chevron marks pointing to the origin of the fracture. Also, the received device conforms to the hardness and dimensional specifications as given in the drawing. 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 instructions for use instructs user that: ¿the surgeon must warn the patient that the device cannot and does not replicate a normal healthy bone, that the device can break or become damaged as a result of strenuous activity, trauma, mal-union or non-union and that the device has a finite expected service life and may need to be removed at some time in the future. Explain the need to report unusual changes in the implantation area as well as falls or accidents even if the device or the site of operation did not appear to be harmed at the time. Explain also the need to appear for the postoperative examinations (e. G. X-ray checks) and for the possible explantation of the implant. ¿ based on investigation, the root cause was attributed to a patient related issue. The failure was caused due to stumbling of the patient over a curb. This fall resulted in the nail breakage. If any further information is provided, the complaint report will be updated.

• Brand Name: LONG NAIL KIT R1.5, TI, RIGHT GAMMA3 11X380MM X 125
• Type of Device: 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: 10996126
• Report Number: 0009610622-2020-00916
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 07613252273844
• UDI-Public: 07613252273844
• Combination Product (y/n): N
• PMA/PMN Number: K034002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 3425-1380S
• Device Catalogue Number: 34251380S
• Device Lot Number: K089DFE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2021

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 02/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Age: 68 YR
• Patient Outcome(s): Required Intervention