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

Model Number 3060-0105S

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Necrosis (1971)

Event Date 01/27/2021

Event Type  Injury  

Manufacturer Narrative

Device will not be returned.If additional information becomes available, it will be provided in a supplemental report.

Event 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.".

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 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
• 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: 11369170
• MDR Text Key: 233258115
• Report Number: 0009610622-2021-00291
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 04546540374950
• UDI-Public: 04546540374950
• Combination Product (y/n): N
• PMA/PMN Number: K200869
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 04/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Manufacturer Received: 04/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR
• Patient Weight: 73