MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.5MM LCP® METAPHYSEAL PLATE 6 HOLES; APPLIANCES, FIXATION, NAIL/BLD/ PL COMBO, MULTI COMP, METAL COM

Model Number	223.406
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Impaired Healing (2378)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: date of non-union is unknown.Date of implantation 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 device history records review has been requested.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 hardware removal of the locking compression plate (lcp) metaphyseal plate and four (4) cortex screws on (b)(6) 2018 due to non-union.The patient was revised to a new plate.The surgeon also used bone void (vivigen 5cc).The procedure was completed successfully, with no reported delay.Patient outcome was stable.This report is for a 3.5mm lcp® metaphyseal plate 6 holes.This is report 2 of 2 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 history records review was completed for part# 223.406, lot# 8979756.Manufacturing location: grenchen, release to warehouse date: may 15, 2014.The device history record shows this lot of 12 pieces was processed through the normal manufacturing and inspection operations with no rework or nonconformity noted.This lot met all dimensional, visual and material criteria at the time of release with no issues documented during the manufacturing process.Review of the device history records showed that there were no issues during the manufacture of the product 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: 3.5MM LCP® METAPHYSEAL PLATE 6 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: 7539976
• Report Number: 2939274-2018-52285
• Device Sequence Number: 19298338
• Product Code: LXT
• UDI-Device Identifier: 10886982157584
• UDI-Public: (01)10886982157584
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K033805
• 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): 05/04/2018

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?: No
• Operator of Device: Health Professional
• Device Model Number: 223.406
• Device Catalogue Number: 223.406
• Device Lot Number: 8979756
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/04/2018
• Supplement Date Received by Manufacturer: 06/21/2018
• Initial Report FDA Received Date: 05/24/2018
• Supplement Report FDA Received Date: 06/22/2018
• 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
• Patient Age: 79 YR
• Patient Weight: 88