MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LONG NAIL KIT R1.5, TI, LEFT GAMMA3 11X340MM X 125; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	3525-1340S
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	06/30/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Device discarded by the customer.
Event or Problem Description
It was reported that a gamma nail broke and a revision surgery (tep) was required.
Additional Manufacturer Narrative
The reported event could be confirmed, although the device was not returned; a few x-rays were provided which confirms the alleged failure.The device inspection was not possible as the product was not returned for investigation.The device history record could not be reviewed because the affected device was not returned, and the lot number was not communicated.A review of the labeling did not indicate any abnormalities.A few x-rays were provided which were presented to our health care professional for evaluation, question about most likely reason for breakage of nail was asked, to which medical expert opined: ¿there is a patient related factor due to the fracture pattern: subtrochanteric fracture with a large lesser trochanter fragment which is dislocated pretty much.Obviously there was also a subtrochanteric communition as there were two cerclages provided.The other is the poor eccentric positioning of the lag screw.It is positioned too low (ap view) and the lengths is not optimally chosen (can be seen on the lateral view).Therefore non-union occurred and the device failed in the end.¿ the device must be available in order to determine the exact root cause of the failure.However, based on the available information and the opinion received from the health care professional, the most probable cause of the issue is most likely patient related.If device is returned or any further information is provided, the investigation report will be reassessed.
Event or Problem Description
It was reported that a gamma nail broke and a revision surgery (tep) was required.Update: while reviewing the x-rays, we can notice that, there is breakage of distal locking screw as well.

• Brand Name: LONG NAIL KIT R1.5, TI, LEFT GAMMA3 11X340MM 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: 12212982
• Report Number: 0009610622-2021-00618
• Device Sequence Number: 11722467
• Product Code: HSB
• UDI-Device Identifier: 07613252274278
• UDI-Public: 07613252274278
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K200869
• 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): 09/28/2021

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 Model Number: 3525-1340S
• Device Catalogue Number: 35251340S
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/30/2021
• Supplement Date Received by Manufacturer: 09/02/2021
• Initial Report FDA Received Date: 07/22/2021
• Supplement Report FDA Received Date: 09/28/2021
• 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: Hospitalization; Required Intervention