MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 4.5MM LCP CONDYLAR PLATE 10 HOLES/242MM-RIGHT; PLATE, FIXATION, BONE

Model Number	222.660
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Nonunion/Delayed-union Bone Fracture (2369)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).The investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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 (b)(6) 2021, patient underwent a hardware removal due to broken 4.5 lcp condylar plate, broken 5.0 cannulated locking screw, broken 4.5 screw, and nonunion femur.All hardware was removed.Date of implant is unknown.Concomitant devices reported: screws: 5.0 mm cannulated (part number unknown, lot unknown, quantity 5), screws: 6.5 mm and 7.3 mm cannulated (part number unknown, lot unknown, quantity 1), screws: cortex (part number unknown, lot unknown, quantity 3).This report involves one (1) 4.5mm lcp® condylar plate 10 holes/242mm-right.This is report 1 of 10 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: h3, h4, h6: product was not returned.Based on the information available, it has been determined that no corrective and preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable device history lot = > part number: 222.660 lot number: 5094299 part manufacture date: 27-oct-2005 manufacturing location: elmira part expiration date: n/a nonconformance noted: n/a dhr record review: a review of the device history record revealed no complaint related anomalies.The device history record shows this lot of 4.5mm lcp® condylar plate 10 holes/242mm-right product was processed through the normal manufacturing and inspection operations with one rework, but no nonconformities noted.The rework consisted inspecting lot 5094299 for ¿suspected burrs on head holes¿.The burrs were not confirmed, and the lot was released for continued processing.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.Device history batch = > null device history review = > 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.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 10 HOLES/242MM-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: 11315775
• Report Number: 2939274-2021-00800
• Device Sequence Number: 2555597
• Product Code: HRS
• UDI-Device Identifier: 10886982157362
• UDI-Public: (01)10886982157362
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K000066
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/24/2021

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 Expiration Date: 11/03/2025
• Device Model Number: 222.660
• Device Catalogue Number: 222.660
• Device Lot Number: 5094299
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/24/2021
• Supplement Date Received by Manufacturer: 03/05/2021
• Initial Report FDA Received Date: 02/11/2021
• Supplement Report FDA Received Date: 03/15/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - SCREWS: 5.0 MM CANNULATED; UNK - SCREWS: 6.5 MM AND 7.3 MM CANNULATED; UNK - SCREWS: CORTEX
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 57 YR