MAUDE Adverse Event Report: WRIGHTS LANE: SYNTHES USA PRODUCTS LLC 2.7MM VA-LCP LATERAL DISTAL FIBULA PLATE/4 HOLES/LEFT; PLATE, FIXATION, BONE

Model Number	02.118.403
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Injury (2348); Not Applicable (3189)
Date of Event	12/04/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This report is for a plate/unknown lot.Lot number is unknown.(b)(4).The device was removed from the patient intraoperatively.Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported that a patient underwent a procedure to repair an unknown fibula fracture on (b)(6) 2017.During the procedure, while the surgeon was implanting a 2.7 mm variable angle (va) locking screw, the surgeon was unable to get the screw to lock into the 2.7mm/3.5 mm va fibula plate.The surgeon removed the screw, re-drilled at a different angle, and attempted to implant a new screw.There was a reported delay of 5 minutes while the surgeon re-drilled the hole.Later, the surgeon was again unable to get the new screw to engage with the plate and elected to complete the procedure after implanting only 4 screws.The surgery was completed and no adverse event reported against the patient this complaint involves three (3) devices.Concomitant devices reported: unknown 2.7mm va screws (part #: unknown, lot #: unknown, qty.4).This report is for 1 (one) plate.(b)(4).

• Brand Name: 2.7MM VA-LCP LATERAL DISTAL FIBULA PLATE/4 HOLES/LEFT
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): WRIGHTS LANE: SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7157584
• Report Number: 2939274-2018-50014
• Device Sequence Number: 10962886
• Product Code: HRS
• UDI-Device Identifier: 10886982038845
• UDI-Public: (01)10886982038845(10)LOTUNKNOWN
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K120854
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 12/04/2017

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: Health Professional
• Device Model Number: 02.118.403
• Device Catalogue Number: 02.118.403
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/04/2017
• Initial Report FDA Received Date: 01/02/2018
• 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: Required Intervention
• Patient Age: 42 YR
• Patient Weight: 119