MAUDE Adverse Event Report: STRYKER GMBH BROAD LOCKING PLATE VARIAX2 MINI FRAGMENT 2.7; L:108MM / 12 HOLES; PLATE, FIXATION, BONE

Catalog Number	629752S
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/19/2023
Type of Reportable Event	Malfunction
Event or Problem Description
As reported: "during an or on (b)(6) 2010, a variax mini fragment was partially broken.It concerns article number 629752s.Lot.Nr 1000464996.Update: plate torn; complaint arose during use".
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Additional Manufacturer Narrative
The reported event could be confirmed based on the inspection performed.The device inspection revealed the following: the identification of the returned plate was confirmed based on the lot # marked on it and the catalog # and lot # marked on the patient record label (picture received from the customer).The breakage of the implant could be confirmed.The breakage occurred around the locking hole at the middle of the plate.The plate is highly bent.Parallel marks close to the breakage on both sides of the plate indicate the use of plate bender.This confirms that the plate was excessively bent during the implantation, leading to the breakage.Dimensional inspection showed the device to be according to the specifications.Based on investigation, the root cause was attributed to a user related issue.The failure was caused by excessive bending of the plate before implantation, which should be avoided, especially around a screw hole.As a reminder, the instructions for use clearly state that: "contouring or bending of an implant should be avoided where possible, because it may reduce its fatigue strength and can cause failure under load.If contouring is necessary, allowed by design or prescribed by stryker, the physician should avoid sharp bends, reverse bends or bending the device at a screw hole.Such action must be performed with stryker instruments and in accordance with the specified procedures (see operative technique)." 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.No indications of material, manufacturing or design related problems were found during the investigation.If more information is provided, the case will be reassessed.
Event or Problem Description
As reported: "during an or on 19 july 2010, a variax mini fragment was partially broken.It concerns article number (b)(4).Lot.Nr 1000464996.Update: plate torn, complaint arose during use.".

• Brand Name: BROAD LOCKING PLATE VARIAX2 MINI FRAGMENT 2.7; L:108MM / 12 HOLES
• 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: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 17632700
• Report Number: 0008031020-2023-00312
• Device Sequence Number: 7645018
• Product Code: HRS
• UDI-Device Identifier: 07613327397680
• UDI-Public: 07613327397680
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K191412
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2026
• Device Catalogue Number: 629752S
• Device Lot Number: 1000464996
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/02/2023
• Supplement Date Received by Manufacturer: 10/26/2023
• Initial Report FDA Received Date: 08/28/2023
• Supplement Report FDA Received Date: 11/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/24/2021
• 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
• Patient Sex: Unknown