MAUDE Adverse Event Report: ARTHREX, INC. POSTERIOR DISTAL TIBIA PLATE, SS, 5H; PLATE, FIXATION, BONE

Model Number	POSTERIOR DISTAL TIBIA PLATE, SS, 5H
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	11/21/2019
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 that during an posterior malleolar fracture reduction surgery the arthrex posterior distal tibia plate - ar-8963p-05 - batch 5261808 was used.Upon insertion of screw into the oblong hole, the screw passed right through the plate resulting in loss of fracture reduction and the use of the plate as a buttress.The surgeon had to resort to 46mm screws with washers (ar-8840c-46 + ar-8870w x 3) to reduce the fracture.As a result the patient will be non weight bearing for approx 6 weeks.No further information received.Update 22-nov-2019: a 2.5mm drill was used in preparation for a 3.5mm cortical screw.The implant was put into the posterior distal tibia.
Additional Manufacturer Narrative
Complaint not confirmed, despite the oblong hole edge being damaged, the screws returned were found to seat without falling off.It is unclear which screw p/n advanced through the plate during the event.The most likely causes include misaligned insertion and a potential combination of the damaged edges.

• Brand Name: POSTERIOR DISTAL TIBIA PLATE, SS, 5H
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 9443929
• Report Number: 1220246-2019-01471
• Device Sequence Number: 19374951
• Product Code: HRS
• UDI-Device Identifier: 00888867221024
• UDI-Public: 00888867221024
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K151732
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/30/2020

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: POSTERIOR DISTAL TIBIA PLATE, SS, 5H
• Device Catalogue Number: AR-8963P-05
• Device Lot Number: 5261808
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 11/21/2019
• Supplement Date Received by Manufacturer: 11/21/2019
• Initial Report FDA Received Date: 12/10/2019
• Supplement Report FDA Received Date: 01/30/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other