MAUDE Adverse Event Report: WRIGHTS LANE: SYNTHES USA PRODUCTS LLC 2.7MM/3.5MM LCP LATERAL DISTAL FIBULA PLATE 5H/RIGHT/99MM; PLATE,FIXATION,BONE

Model Number	02.112.140
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Reaction (2414)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event is unknown.Additional device procode: hwc.Date of implant is an unknown date in (b)(6) 2016.Device is not expected to be returned for manufacturer review/investigation.Device history records review was completed for part# 02.112.140, lot# h045602.Manufacturing location: (b)(4), manufacturing date: feb 25, 2016.A review of the device history record revealed no complaint related anomalies.The device history record shows this lot of 2.7 mm/3.5 mm lcp lateral distal fibula plate 5h/right/99 mm product was processed through the normal manufacturing and inspection operations with no rework nor nonconformities noted.This lot met all dimensional, visual and packaging 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 with no nonconformance noted.This raw material lot met all dimensional and visual criteria at the time of manufacture with no issues documented during the manufacture that would contribute to this complaint condition.Device evaluation/investigation could not be completed; no conclusion could be drawn as product was not returned to manufacturer.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 on an unknown date in (b)(6) 2016, patient underwent surgery to treat a left ankle fracture.Patient was implanted with one (1) 2.7 mm/3.5 mm lcp lateral distal plate and ten (10) screws.It was unknown to the surgeon if the patient was allergic to metal at the time of the initial surgery.Subsequently the patient felt some soft tissue irritation and this was discovered to be a reaction to metal allergy.The surgeon then decided to remove all implanted devices and the construct with all devices intact was removed on (b)(6) 2018.Intra-operative x-rays taken suggested that the fracture had completely healed.The removal of plate and screws construct was completed successfully and without any complications.No additional interventions were required and there was no surgical delay.The patient was reported to be in stable condition.This report is for one (1) 2.7 mm/3.5 mm lcp lateral distal fibula plate 5h/right/99 mm.This is report 1 of 11 for (b)(4).

• Brand Name: 2.7MM/3.5MM LCP LATERAL DISTAL FIBULA PLATE 5H/RIGHT/99MM
• 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: 7242148
• Report Number: 2939274-2018-50514
• Device Sequence Number: 997556
• Product Code: HRS
• UDI-Device Identifier: 10886982033932
• UDI-Public: (01)10886982033932(10)H045602
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K083213
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 01/15/2018

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: 02.112.140
• Device Catalogue Number: 02.112.140
• Device Lot Number: H045602
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/15/2018
• Initial Report FDA Received Date: 02/05/2018
• 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: Required Intervention
• Patient Weight: 82