MAUDE Adverse Event Report: SYNTHES ELMIRA 2.7MM/3.5MM LCP LATERAL DISTALFIBULA PLATE 4H/RIGHT/86MM; PLATE,FIXATION,BONE

Catalog Number	02.112.138
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Renal Failure (2041); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Exact date of implant is unknown.Implant procedure sometimes in (b)(6) 2016.Device is not expected to be returned for manufacturer review/investigation.(b)(4).Device history records review was completed for part# 02.112.138, lot# 9959197.Manufacturing location: (b)(4), manufacturing date: dec 08, 2015.A review of the device history record revealed no complaint related anomalies.The device history record shows this lot of lcp lateral distal fibula plates was processed through the normal manufacturing and inspection operations with no non-conformances or rework noted.This order met all dimensional and visual criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.A review of the raw material device history record revealed this lot met all specifications at time of acceptance.No nonconforming reports were noted.The raw material met all dimensional and visual criteria at the time of release with no issues documented.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 had hardware removal on (b)(6) 2017 due to being septic.Patient was initially implanted with a 2.7mm/3.5mm locking compression plate (lcp), four 2.7mm locking screws, and three 3.5mm cortex screws in (b)(6) 2016 for a broken distal fibula.There were no reported complications during the initial surgery.It is unknown how the infection was discovered and how it was confirmed.The location and type of infection is unknown.On the day of the removal surgery, in addition to being septic, patient was presented with renal failure.It is unknown if patient had renal failure prior to the initial implantation of the hardware.Surgeon stated that the patient was in a state of dying.All hardware was removed intact.There were no issues with the hardware.No new hardware was implanted.The removal surgery was successfully completed without requiring intervention.No surgical delay reported.Patient status/outcome is unknown.This report is for one (1) lcp lateral distal fibula plate.This is report 1 of 3 for (b)(4).
Additional Manufacturer Narrative
Reporter profession: manager of quality control and central sterile.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 2.7MM/3.5MM LCP LATERAL DISTALFIBULA PLATE 4H/RIGHT/86MM
• Common Device Name: PLATE,FIXATION,BONE
• Manufacturer (Section D): SYNTHES ELMIRA; 35 airport road; horseheads NY 14845
• MDR Report Key: 6367935
• Report Number: 3003506883-2017-10026
• Device Sequence Number: 13710883
• Product Code: HRS
• UDI-Device Identifier: 10886982033895
• UDI-Public: (01)10886982033895(10)9959197
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K083213
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/05/2017

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: Physician
• Device Catalogue Number: 02.112.138
• Device Lot Number: 9959197
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/05/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/01/2017
• Supplement Report FDA Received Date: 03/08/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention