MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 4.5MM LCP® CONDYLAR PLATE 8 HOLES/206MM-RIGHT; PLATE,FIXATION,BONE

Model Number	222.658
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Not Applicable (3189)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient weight is unknown.Additional device product codes: hty, jdw, hwc.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, on an unknown date, the patient underwent removal of the locking compression condylar plate, cannulated locking screws and cortex screws due to non-union.It is unknown if there was a surgical delay.There was no patient consequence reported.All hardware was successfully removed with no issue.This is report 1 of 4 for (b)(4).
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Additional narrative: device evaluated by mfr, device manufacture date.Device history record (dhr) review: part mfg date: 06-jan-2011; part exp.Date: n/a; manufacturing location: depuy synthes ¿ elmira; lot number: 6561086; part number: 222.658.Dhr record review: a review of the device history record (dhr) revealed no non-conformances.The dhr shows lot#: 6561086 of 4.5mm lcp condylar plate 8 holes/206mm-right was processed through the normal manufacturing and inspection operations with no nonconformances or reworks 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.This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during manufacture that would contribute to this complaint condition.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: 4.5MM LCP® CONDYLAR PLATE 8 HOLES/206MM-RIGHT
• 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: 7829678
• Report Number: 2939274-2018-53537
• Device Sequence Number: 2434571
• Product Code: HRS
• UDI-Device Identifier: 10886982157324
• UDI-Public: (01)10886982157324
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K000066
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/13/2018

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: 222.658
• Device Catalogue Number: 222.658
• Device Lot Number: 6561086
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/13/2018
• Supplement Date Received by Manufacturer: 09/14/2018
• Initial Report FDA Received Date: 08/29/2018
• Supplement Report FDA Received Date: 09/25/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 77 YR