MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 4.5MM/3.5MM LCP® METAPHYSEAL PLATE 13 HOLES; APPLIANCES,FIXATION,NAIL/BLD/PL COMBO,MULTI COMP, METAL COM

Model Number	224.758
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Nonunion/Delayed-union Bone Fracture (2369); No Code Available (3191)
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 an unknown date, the patient underwent an open reduction internal fixation (orif) of tibia, the locking compression plate (lcp) metaphyseal plate 13 holes was placed on the midshaft tibia to proximal half.The non-union and weight bearing caused the plate to snap postoperatively.It is unknown if there was surgical delay.Procedure and patient outcome are unknown.Concomitant device reported: unknown screws (part # unknown, lot # unknown, quantity # unknown).This report is for one (1) 4.5mm/3.5mm lcp metaphyseal plate.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.Investigation summary product was not returned.Based on the information available, it has been determined that no corrective and preventive 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: 224.758, lot: 2716475, manufacturing site: bettlach, release to warehouse date: 16.Mar.2011.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.The raw material certificate 13673 was reviewed and the used material was according to iso-5832-1 specification for implants for surgery.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/3.5MM LCP® METAPHYSEAL PLATE 13 HOLES
• 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: 8437040
• Report Number: 2939274-2019-57041
• Device Sequence Number: 2227866
• Product Code: LXT
• UDI-Device Identifier: 10886982158727
• UDI-Public: (01)10886982158727
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K033805
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/25/2019

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: 224.758
• Device Catalogue Number: 224.758
• Device Lot Number: 2716475
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/25/2019
• Supplement Date Received by Manufacturer: 04/19/2019
• Initial Report FDA Received Date: 03/20/2019
• Supplement Report FDA Received Date: 04/22/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention