MAUDE Adverse Event Report: STRYKER TRAUMA KIEL FEMORAL NAIL GT, LEFT T2 ALPHA FEMUR ANTEGRADE 9X340MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	2331-0934S
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	10/05/2020
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 is not available; hospital retained.
Event or Problem Description
"it was reported that the patient's left femur was revised due to the alpha gt nail being bent approximately 30-40°.Surgeon reported the cause was due to the patient having gotten into a fight in the psychiatric ward.A 9x340 nail and 2 80mm 6.5 lag screws were revised.".
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 evidences were 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.A review of the labeling did not indicate any abnormalities.More information as well as the device must be available in order to determine the exact root cause.However, based on the event, the most probable cause of the failure is patient¿s improper post-operative care which is patient related.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
"it was reported that the patient's left femur was revised due to the alpha gt nail being bent approximately 30-40°.Surgeon reported the cause was due to the patient having gotten into a fight in the psychiatric ward.A 9x340 nail and 2 80mm 6.5 lag screws were revised.".

• Brand Name: FEMORAL NAIL GT, LEFT T2 ALPHA FEMUR ANTEGRADE 9X340MM
• 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: 10757865
• Report Number: 0009610622-2020-00619
• Device Sequence Number: 19666642
• Product Code: HSB
• UDI-Device Identifier: 07613327284669
• UDI-Public: 07613327284669
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K191271
• 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): 12/28/2020

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: 04/30/2024
• Device Model Number: 2331-0934S
• Device Catalogue Number: 23310934S
• Device Lot Number: K0559A3
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/05/2020
• Supplement Date Received by Manufacturer: 12/03/2020
• Initial Report FDA Received Date: 10/29/2020
• Supplement Report FDA Received Date: 12/28/2020
• 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: 21 YR
• Patient Weight: 84