MAUDE Adverse Event Report: WRIGHTS LANE : SYNTHES USA PRODUCTS LLC LOCKING CALCANEAL PLATE MINI-RIGHT; APPLIANCES,FIXATION,NAIL/BLD/PL COMBO,MULTI COMP, METAL COM

Model Number	241.618
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Pain (1994)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient date of birth and weight not available for reporting.Date of event: unknown.Date of implant reported as approximately 7 years prior to explant.Complainant part is not expected to be returned for manufacturer review/investigation.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 hardware removal was performed on (b)(6) 2018 due to patient pain and possible infection, there was also drainage at the surgical site.A locking calcaneal plate, 12 locking screws and one cortical screw were removed.All parts were intact, no malfunctions.No revision surgery was performed, no additional x-rays were taken.The surgery was completed successfully without any surgical delays and the patient status was noted as stable.The original surgery was for an open reduction and internal fixation (orif) of a calcaneus fracture.The original surgery date is unknown but was performed approximately seven years prior to removal.This report is for one (1) locking calcaneal plate mini-right.This is report 1 of 3 for (b)(4).
Additional Manufacturer Narrative
Device history record (dhr) review: part mfg date: 20-nov-2008, part exp.Date: n/a, manufacturing location: depuy synthes ¿ (b)(4): part number: 241.618, lot number: 6022445: dhr record review: a review of the device history record (dhr) revealed no nonconformances.The dhr shows lot# 6022445 of locking calcaneal plate mini-right was processed through the normal manufacturing and inspection operations with no nonconformances or rework noted.This 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.A review of the raw material dhr revealed this lot met all specifications with no nonconformances or rework noted.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.

• Brand Name: LOCKING CALCANEAL PLATE MINI-RIGHT
• Common Device Name: APPLIANCES,FIXATION,NAIL/BLD/PL COMBO,MULTI COMP, METAL COM
• Manufacturer (Section D): WRIGHTS LANE : SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7252933
• Report Number: 2939274-2018-50557
• Device Sequence Number: 13707460
• Product Code: LXT
• UDI-Device Identifier: 10886982167361
• UDI-Public: (01)10886982167361(10)6022445
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K991407
• 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,Followup
• Report Date (Section B): 01/20/2018

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: 241.618
• Device Catalogue Number: 241.618
• Device Lot Number: 6022445
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/20/2018
• Supplement Date Received by Manufacturer: 03/13/2018
• Initial Report FDA Received Date: 02/08/2018
• Supplement Report FDA Received Date: 03/16/2018
• 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: 70 YR