MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.5MM LCP PLATE 9 HOLES 124MM; PLATE,FIXATION,BONE

Model Number	223.591
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Pain (1994); Nonunion/Delayed-union Bone Fracture (2369)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event is unknown.Additional device product codes hwc and ktt.Explant date: unknown.Device is not expected to be returned for manufacturer review/investigation.Device evaluation/investigation could not be completed; no conclusion could be drawn as product was not returned to manufacturer.Additionally, device history records review could not be completed without lot number.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) 2011 patient underwent revision surgery of right total hip arthroplasty with cup cage construct and plate with well-fixed reasonably positioned components.Post-operative on (b)(6) 2013, patient had an x-ray due to pain that revealed a broken posterior column plate and a broken ischial flange on the cage.Patient also had a non-union with degenerative changes in the sacroiliac joint was well as lumber spine.It is unknown if the patient had a revision surgery.The surgeon's decided to monitor for migration.Concomitant devices reported: locking self tapping screw 212.104 quantity 1, locking self tapping screw 212.110 quantity 1, locking self tapping screw 212.112 quantity 2, locking self tapping screw 212.113 quantity 3, locking self tapping screw 212.213 quantity 1.(b)(4) captures depuy joint recon devices.This report is for one (1) 3.5 mm lcp plate 9 holes 124 mm.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.Other relevant history: updated.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 PLATE 9 HOLES 124MM
• 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: 7837670
• Report Number: 2939274-2018-53553
• Device Sequence Number: 1286756
• Product Code: HRS
• UDI-Device Identifier: 10886982157973
• UDI-Public: (01)10886982157973
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K082807
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/03/2018

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: 223.591
• Device Catalogue Number: 223.591
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/03/2018
• Supplement Date Received by Manufacturer: 09/05/2018
• Initial Report FDA Received Date: 08/31/2018
• Supplement Report FDA Received Date: 09/25/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Weight: 86