MAUDE Adverse Event Report: ARTHREX, INC. LOCK DISTAL FIBULA PLT,SS RT,5H; PLATE, FIXATION, BONE

Model Number	LOCK DISTAL FIBULA PLT,SS RT,5H
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	07/12/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
There was no damage or anomaly observed that would have contributed to the reported event.The device met all dimensional specification as received.At this time, it cannot be determined if the device may have caused or contributed to the patient¿s experience.
Event or Problem Description
It was reported via facility medwatch report (b)(4) that the patient presented to the hospital for a displaced previous fixation ((b)(6) 2018) of the right distal fibula and required removal of deep implant from right ankle distal fibula and open reduction and internal fixation of right fibula.The surgeon documented the patient had received the surgical fixation for the previous procedure three weeks prior and currently had a posterolateral dislocation of the ankle again with choice of revision fixation.The surgeon's documentation revealed the patient's previous plate during surgery was noted to have pulled off the fibula.The distal screws and fibula were then removed and when plate was extracted, the fracture site was identified and the proximal fibula shaft identified.The surgeon also documented that immediately during the revision surgery, the patient was noted to have very good soft tissue medially with no fracture blisters.No other complications were reported.Additional information obtained 8/21/2018: the facility has confirmed that they do not have any further information with regard to the part numbers of the screws that were explanted with the 10 hole plate.A different 8 hole plate was used in place of the 10 hole plate but not specific details were found by the facility.Patient bone was described, per facility, as "incredibly soft".Facility has the plate and screws and will release for return to arthrex for evaluation.Facility has provided arthrex with an x-ray picture showing the plate pulled away from the bone prior to explant surgery.

• Brand Name: LOCK DISTAL FIBULA PLT,SS RT,5H
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 7846675
• Report Number: 1220246-2018-00625
• Device Sequence Number: 2726424
• Product Code: HRS
• UDI-Device Identifier: 00888867052567
• UDI-Public: 00888867052567
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K141478
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 09/05/2018

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: LOCK DISTAL FIBULA PLT,SS RT,5H
• Device Catalogue Number: AR-8943BR-05
• Device Lot Number: 105641628
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/16/2018
• Initial Report FDA Received Date: 09/05/2018
• 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
• Patient Weight: 65