MAUDE Adverse Event Report: STRYKER GMBH DISTAL ANTEROLATERAL TIBIA PLATE AXSOS 3 FOR RIGHT TIBIA 8 HOLE / L153MM; PLATE, FIXATION, BONE

Model Number	627488
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/22/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device will not be returned.If additional information becomes available, it will be provided in a supplemental report.
Event or Problem Description
The customer reported the following issue: pi linked to pi 2869190, this pi is about the revision surgery."fusion of the plate and screws installed two months ago.Therefore, problem with removal during revision surgery.Longer operation time and increased anaesthesia time".
Additional Manufacturer Narrative
The reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.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.A review of the device history was not possible because the communicated lot number was not valid.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
The customer reported the following issue: pi linked to pi (b)(6), this pi is about the revision surgery."fusion of the plate and screws installed two months ago.Therefore, problem with removal during revision surgery.Longer operation time and increased anaesthesia time".

• Brand Name: DISTAL ANTEROLATERAL TIBIA PLATE AXSOS 3 FOR RIGHT TIBIA 8 HOLE / L153MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer Contact: sharon rivas ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 13066760
• Report Number: 0008031020-2021-00505
• Device Sequence Number: 4255831
• Product Code: HRS
• UDI-Device Identifier: 07613327082210
• UDI-Public: 07613327082210
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K200398
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/19/2022

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 Model Number: 627488
• Device Catalogue Number: 627488
• Device Lot Number: 1430758
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/26/2021
• Supplement Date Received by Manufacturer: 12/23/2021
• Initial Report FDA Received Date: 12/22/2021
• Supplement Report FDA Received Date: 01/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown