MAUDE Adverse Event Report: STRYKER TRAUMA KIEL TROCHANTERIC NAIL KIT, TI GAMMA3® Ø10X170MM X 125°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	31250170S
Health Effect - Clinical Code	Necrosis (1971)
Date of Event	05/07/2019
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 evaluated by mfr: hospital policy.
Event or Problem Description
Rep reported that the surgeon revised a gamma nail to a rest mod tha with mdm.The patient received the gamma nail about 2 years ago for a femoral fracture, then developed avascular necrosis.Subsequent collapse of the femoral head has resulted in the lag screw protruding into the joint space requiring revision.
Event or Problem Description
Rep reported that the surgeon revised a gamma nail to a rest mod tha with mdm.The patient received the gamma nail about 2 years ago for a femoral fracture, then developed avascular necrosis.Subsequent collapse of the femoral head has resulted in the lag screw protruding into the joint space requiring revision.
Additional Manufacturer Narrative
The reported event could not be confirmed, since the device was not returned for evaluation and no other evidence was provided.A device inspection was not possible since the affected device was not returned, and no other evidence was provided for investigation.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.The occurrence of (avascular) necrosis is usually caused by decreased blood supply.It is primarily not associated with an implant device but is rather a result of disruption of blood supply.A correlation to the treatment (insertion procedure and / or fracture healing) cannot be excluded.However, the incidence of a necrosis is not directly contributed by an implant.Avascular necrosis is known in the medical science.It is discussed that unstable, dislocated fractures ¿ possibly due to technical failure at surgery ¿ may contribute to avascular necrosis.With available information the cause of the event was most likely based on the patient¿s condition and / or on surgical technique but not caused by a deficiency of the device.A review of the labeling did not indicate any abnormalities.The labelling also mentions ¿deep venous thrombosis & avascular necrosis¿ among possible adverse effects and that the ¿adverse results may be clinically related rather than device related.¿ if the device is returned or if any additional information is provided, the investigation will be reassessed.

• Brand Name: TROCHANTERIC NAIL KIT, TI GAMMA3® Ø10X170MM 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
• MDR Report Key: 8631624
• Report Number: 0009610622-2019-00280
• Device Sequence Number: 16629675
• Product Code: HSB
• UDI-Device Identifier: 04546540375063
• UDI-Public: 04546540375063
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K034002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/24/2019

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 08/31/2021
• Device Catalogue Number: 31250170S
• Device Lot Number: K0D8E59
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/07/2019
• Supplement Date Received by Manufacturer: 06/27/2019
• Initial Report FDA Received Date: 05/22/2019
• Supplement Report FDA Received Date: 07/24/2019
• 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: 89 YR