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

Model Number 627488

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

Patient Problem Insufficient Information (4580)

Event Date 08/22/2021

Event Type  Injury  

Manufacturer Narrative

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

Event 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".

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 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
• Type of Device: 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
• MDR Text Key: 282713241
• Report Number: 0008031020-2021-00505
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 07613327082210
• UDI-Public: 07613327082210
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K200398
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Manufacturer Received: 12/23/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization