MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LAG SCREW, TI GAMMA3 10.5X105MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	3060-0105S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Necrosis (1971)
Date of Event	01/27/2021
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.
Event or Problem Description
"it was reported that the patient's left femur was revised due to avascular necrosis.Rep confirmed there are no allegations against the revised implants.A gamma nail, set screw, lag screw, and distal screw were revised.".
Additional Manufacturer Narrative
The reported event could not be confirmed, since no evidence to confirm it was provided for evaluation.Implant revision sheet and device images were provided, which are not sufficient to confirm the event.The device inspection was not possible as the product was not returned 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 detailed information about the complaint event and patient's medical records must be available in order to determine the root cause of the alleged necrosis.If device is returned or any further information is provided, the investigation report will be reassessed.
Event or Problem Description
"it was reported that the patient's left femur was revised due to avascular necrosis.Rep confirmed there are no allegations against the revised implants.A gamma nail, set screw, lag screw, and distal screw were revised.".

• Brand Name: LAG SCREW, TI GAMMA3 10.5X105MM
• 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: 11369170
• Report Number: 0009610622-2021-00291
• Device Sequence Number: 934685
• Product Code: HSB
• UDI-Device Identifier: 04546540374950
• UDI-Public: 04546540374950
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K200869
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2021

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 08/31/2018
• Device Model Number: 3060-0105S
• Device Catalogue Number: 30600105S
• Device Lot Number: K05ECCE
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/27/2021
• Supplement Date Received by Manufacturer: 04/01/2021
• Initial Report FDA Received Date: 02/23/2021
• Supplement Report FDA Received Date: 04/28/2021
• 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: 71 YR
• Patient Weight: 73