MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 4.5MM VA-LCP CURVED CONDYLAR PLATE/10HOLE/230MM/LT-STER; PLATE, FIXATION, BONE

Model Number	02.124.411S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of postoperative plate breakage is unknown.Additional device product codes: jdp, hwc.Original implant date is reported as (b)(6) 2018; exact date is unknown.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.A review of the device history records has been requested and is currently pending completion.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 the patient underwent a revision surgery on (b)(6) 2018, due to a broken variable angle (va) - locking compression plate (lcp) curved condylar plate.The patient was experiencing pain.On an unknown date, an x-ray was taken and revealed a broken plate.Ten (10) unknown screws were also removed fully intact.Original implant date was (b)(6) 2018.The patient was revised to stryker devices.The procedure was completed successfully.No additional medical intervention was necessary.The patient was stable following surgery.Concomitant devices reported: unknown screws (part number: unknown, lot number: unknown, quantity: 10).This report is for one (1) 4.5mm va-lcp curved condylar plate/10hole/230mm/lt-ster.This is report 1 of 1 for complaint (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.Dhr review was completed.Part: 02.124.411s, lot: l620561 , manufacturing site: mezzovico , release to warehouse date: 16.Nov.2017 , expiry date: 01.Nov.2027.The device history record shows this lot of 12 pieces was processed through the normal manufacturing and inspection operations with no rework or nonconformities noted.This lot met all dimensional and visual criteria at the time of release with no issues documented during the manufacturing process.The review of the forging blank 60067385 with lot l460004 has shown that the used material was according to norm for stainless steel implants for surgery review of the device history record showed that there were no issues during the manufacture of this product which 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 VA-LCP CURVED CONDYLAR PLATE/10HOLE/230MM/LT-STER
• 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: 7820415
• Report Number: 2939274-2018-53497
• Device Sequence Number: 1808263
• Product Code: HRS
• UDI-Device Identifier: 10886982042842
• UDI-Public: (01)10886982042842
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K110354
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/08/2018

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: 02.124.411S
• Device Catalogue Number: 02.124.411S
• Device Lot Number: L620561
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/08/2018
• Supplement Date Received by Manufacturer: 08/28/2018
• Initial Report FDA Received Date: 08/27/2018
• Supplement Report FDA Received Date: 09/25/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 79 YR