MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 4.5MM LCP® CONDYLAR PLATE 12 HOLES/278MM/RIGHT-STERILE; PLATE,FIXATION,BONE

Model Number	222.662S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient information is unknown.Date of event is unknown.Additional classification codes: hwc, hty, jdw.Implant date is unknown.Complainant part availability is unknown.Without a lot number the device history records review could not be completed.The manufacture date is unknown.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 shaft of the patient's implanted variable angle (va)-locking compression plate (lcp) condylar plate snapped.The patient then underwent hardware revision surgery on (b)(6) 2018, where the broken plate was removed easily and replaced.There was no patient information reported.It is unknown if there was surgical delay and what the patient outcome was.No additional information available.This is report 1 of 1 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.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 shaft of the patient's implanted 4.5mm locking compression plate (lcp) condylar plate snapped.The patient then underwent hardware revision surgery on (b)(6) 2018, where the broken plate was removed easily and replaced with a variable angle (va) lcp condylar plate.It is unknown if there was surgical delay and what the patient outcome was.

• Brand Name: 4.5MM LCP® CONDYLAR PLATE 12 HOLES/278MM/RIGHT-STERILE
• 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: 7515769
• Report Number: 2939274-2018-52188
• Device Sequence Number: 13835204
• Product Code: HRS
• UDI-Device Identifier: 10886982157416
• UDI-Public: (01)10886982157416
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K000066
• 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): 04/25/2018

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 222.662S
• Device Catalogue Number: 222.662S
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/25/2018
• Supplement Date Received by Manufacturer: 05/29/2018
• Initial Report FDA Received Date: 05/15/2018
• Supplement Report FDA Received Date: 05/29/2018
• 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