MAUDE Adverse Event Report: STRYKER GMBH 2.3 M VARIAX HAND LOCK T-PLATE,WIDE,8HOLES; PLATE, FIXATION, BONE

Model Number	57-15361
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Injury (2348)
Date of Event	05/19/2020
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 disposition is unknown.
Event or Problem Description
As reported: "2.3 plate that was placed to fuse cmc joint hardware broke at the joint.All locking screws were used.On (b)(6) 2020 the doctor removed broken hardware and replaced with a competitor 2.0 stainless steel locking plate.".
Event or Problem Description
As reported: "2.3 plate that was placed to fuse cmc joint hardware broke at the joint.All locking screws were used.On (b)(6) 2020 the doctor removed broken hardware and replaced with a competitor 2.0 stainless steel locking plate.".
Additional Manufacturer Narrative
The reported event could be confirmed, only based on pictures.The plate is indeed broken at the junction of the t-shape.The picture of the broken plate shows that the device should most probably be identified as a three hole plate and not a 4 hole plate.However this could not be confirmed by the customer.More detailed information about the complaint event such as x-rays and patient activity level as well as the affected device must be available in order to determine the root cause of the complaint event.However, as a reminder, even though the variax hand plating system is cleared for joint fusion, it is usually up to the surgeon to decide which plate he prefers to use to ensure stability.A lot of variables are to be considered, such as patient condition (incl.Compliance), age, size, bone geometry, position to place the plate, etc.As well as the surgeon's preference.Based on that, in order to perform joint fusions, t-plates are indeed used, but some surgeons prefer double row plates to increase stability.A review of the device history was not possible because the lot number was not communicated.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.

• Brand Name: 2.3 M VARIAX HAND LOCK T-PLATE,WIDE,8HOLES
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 10155435
• Report Number: 0008031020-2020-01648
• Device Sequence Number: 2420822
• Product Code: HRS
• UDI-Device Identifier: 07613154496716
• UDI-Public: 07613154496716
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K062498
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/20/2020

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 Model Number: 57-15361
• Device Catalogue Number: 57-15361
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/19/2020
• Supplement Date Received by Manufacturer: 06/24/2020
• Initial Report FDA Received Date: 06/15/2020
• Supplement Report FDA Received Date: 07/20/2020
• 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: 55 YR