MAUDE Adverse Event Report: SYNTHES ELMIRA 2.7MM/3.5MM LCP LATERAL DISTALFIBULA PLATE 5H/LEFT/99MM; PLATE, FIXATION, BONE

Model Number	02.112.141
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Wound Dehiscence (1154); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: unknown.Concomitant medical product: (therapy date): implanted two months prior to hardware removal procedure; exact date is unknown.Explant date is unknown.Complainant device is not expected to be returned for manufacturer review/investigation.A review of the device history records has been requested and is currently pending completion.(b)(4).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 the patient experienced wound breakdown around the lateral side of the ankle.A lateral distal fibula plate, five 3.5mm cortex screws, one 2.7mm cortex screw, and five 2.7mm locking screws were originally implanted in order to treat a bimallaleor ankle fracture two months ago.The bone appeared to have healed nicely and the wound did not break down to the hardware.As a precaution, the lateral plates and screws were taken out.No infection was identified and no allegations were made against the implanted devices.All devices were removed easily and no fragments were generated.Concomitant devices reported: unknown 3.5mm cortex screw (part #: unknown, lot #: unknown, qty.5), unknown 2.7mm cortex screw (part #: unknown, lot #: unknown, qty 1), unknown 2.7mm locking screw (part #: unknown, lot #: unknown, qty.5).This report is for one (1) 2.7mm/3.5mm lcp lateral distal fibula plate 5h/left/99mm.This is report 1 of 1 for complaint (b)(4).

• Brand Name: 2.7MM/3.5MM LCP LATERAL DISTALFIBULA PLATE 5H/LEFT/99MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): SYNTHES ELMIRA; 35 airport road; horseheads NY 14845
• MDR Report Key: 6968643
• Report Number: 3003506883-2017-10242
• Device Sequence Number: 16446820
• Product Code: HRS
• UDI-Device Identifier: 10886982033956
• UDI-Public: (01)10886982033956(10)H162004
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K083213
• 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): 10/02/2017

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?: No
• Operator of Device: Health Professional
• Device Model Number: 02.112.141
• Device Catalogue Number: 02.112.141
• Device Lot Number: H162004
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/02/2017
• Initial Report FDA Received Date: 10/23/2017
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 2.7MM CORTEX SCREW (PART & LOT UNKNOWN, QTY 1); 2.7MM LOCKING SCREW (PART & LOT UNKNOWN, QTY 5); 3.5MM CORTEX SCREW (PART & LOT UNKNOWN, QTY 5)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Weight: 160