MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.7/3.5MM VA-LCP MEDIAL DISTAL TIBIA PLATE/10 HOLES/RIGHT; PLATE,FIXATION,BONE

Model Number	02.118.008
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	01/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: unknown date in 2019.(b)(4).The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing 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 (b)(6) 2019, the patient underwent revision of the variable angle locking compression plate (va-lcp) medial distal tibia plate due to a broken plate.The patient had a distal third tibia fracture that was treated in (b)(6) 2019, and came back to the doctor¿s office this week.There were no fragments generated from the broken device.There was no surgical delay reported.Procedure was successfully completed with no patient consequence.Concomitant devices reported: unk - screws: trauma (part# unknown, lot# unknown, quantity# unknown).This report is for one (1) 2.7/3.5mm va-lcp medial distal tibia plate/10 holes/right 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.Additional information provided.Part: 02.118.008; lot: 9927748; manufacturing site: raron; release to warehouse date: may 04, 2016.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Visual inspection the 2.7/3.5mm va-lcp medial distal tibia plate/10 holes/right was returned and received at us customer quality (cq) in two pieces.The plate was observed to be broken in half, with the transverse fracture occurring at the locking hole of the 5th combi-hole (c5).No other issues were identified with the returned components of the device.Dimensional inspection per drawing 2.7mm/3.5mm va-lcp medial distal tibia plate: cross-section k-k measurements were taken at the transverse fracture of the returned implant.Plate thickness: conforming plate width: conforming document/specification review.2.7mm/3.5mm va-lcp medial distal tibia plate - manufacture and current revision investigation conclusion.The complaint was confirmed for the 2.7/3.5mm va-lcp medial distal tibia plate/10 holes/right as the plate was observed to be broken in half, with the transverse fracture occurring at the locking hole of the 5th combi-hole (c5).There was no indication that a design or manufacturing issue contributed to the complaint.While no definitive root cause could be determined, it is possible that condition was due to early excessive strain by patient or the screws incorrectly locked to plate (not properly torqued).Based on the investigation findings, it is determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.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.
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.
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 pulled from archive and returned to customer.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: 2.7/3.5MM VA-LCP MEDIAL DISTAL TIBIA PLATE/10 HOLES/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: 8692268
• Report Number: 2939274-2019-58607
• Device Sequence Number: 2006101
• Product Code: HRS
• UDI-Device Identifier: 10886982037701
• UDI-Public: (01)10886982037701
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K120854
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/15/2019

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: 02.118.008
• Device Catalogue Number: 02.118.008
• Device Lot Number: 9927748
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2019
• Initial Date Received by Manufacturer: 05/15/2019
• Supplement Date Received by Manufacturer: 07/08/2019; 07/08/2019; 09/26/2019
• Initial Report FDA Received Date: 06/12/2019
• Supplement Report FDA Received Date: 07/08/2019; 07/08/2019; 10/17/2019
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - SCREWS: TRAUMA; UNK - SCREWS: TRAUMA; UNK - SCREWS: TRAUMA
• Outcome Attributed to Adverse Event: Required Intervention