MAUDE Adverse Event Report: ARTHREX, INC. PLATE, POW, LOCKING, TI, 7 MM; PLATE, FIXATION, BONE

Model Number	PLATE, POW, LOCKING, TI, 7 MM
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/25/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.
Event or Problem Description
It was reported, the during a post-operative follow-up on for a proximal open wedge bunion procedure on (b)(6) 2020, x-rays shown a broken ar-8953-07, locking plate.The surgeon removed ar-8953-07, ar-8933-v-16 (2), ar-8933v-18(1) and ar-8933v-20(1) on (b)(6) 2020.Additional information obtained 11/11/2020: the patient's original surgery took place (b)(6) 2020.There was no known or reported trauma suffered by the patient post-op.The revision surgery to remove the broken plate and screws was performed (b)(6) 2020.Additional information obtained 11/12/2020: during the revision, upon explantation, it was discovered that the plate and one screw were broken inside the patient.It is unknown at this time which of the screw part numbers: ar-8933-v-16, ar-8933v-18 or ar-8933v-20 is the screw that was broken or if the screw may have broken due to the broken plate that was discovered at one of the patient follow up visits.During the revision there were no new devices implanted.
Additional Manufacturer Narrative
It was reported that during a post-op follow up the plate and one screw were found to be broken.The reported event is confirmed upon investigation of the returned product.Visual evaluation of the plate identified signs of use and a fracture located at the middle screw hole.Evaluation of the screws found that one out of the four screws had fractured as well.However, the broken screw could not be identified or measured due to the fractured state of the screw.The other screws were able to be identified as (2) ar-8933v-16 and (1) ar-8933v-18.The root cause of the reported failure mode is undetermined.However, the most likely probable cause is excessive mechanical forces applied during healing.

• Brand Name: PLATE, POW, LOCKING, TI, 7 MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 10934560
• Report Number: 1220246-2020-02381
• Device Sequence Number: 19907277
• Product Code: HRS
• UDI-Device Identifier: 00888867055216
• UDI-Public: 00888867055216
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K040907
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/09/2020

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?: No
• Operator of Device: Health Professional
• Device Model Number: PLATE, POW, LOCKING, TI, 7 MM
• Device Catalogue Number: AR-8953-07
• Device Lot Number: 95241541
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 11/09/2020
• Supplement Date Received by Manufacturer: 11/09/2020
• Initial Report FDA Received Date: 12/02/2020
• Supplement Report FDA Received Date: 12/09/2020
• 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: Other