MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.4MM VA-LCP DORSAL DISTAL RAD PLATE/RADIAL COLUMN/6H SHAFT; PLATE, FIXATION, BONE

Model Number	02.115.540
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Nonunion/Delayed-union Bone Fracture (2369)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional patient identifier: (b)(6).Date of postoperative nonunion and infection development is unknown.Originally implanted on an unknown date of (b)(6) 2014.Complainant device 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.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 a patient underwent a hardware removal and revision on (b)(6) 2017 due to broken wrist fusion plate, nonunion and infection.Hardware was originally implanted on an unknown date of (b)(6) 2014.The patient is reported to have presented to the surgeon with a broken plate, thus leading to the hardware removal being scheduled.The surgeon removed one (1) wrist fusion plate, one (1) distal radial plate, seven (7) 2.7 mm cortex screws and three (3) 3.5 mm cortex screws, and replaced the hardware with a k-wire fixation including an unknown quantity of k-wires and an antibiotic cement for infection.It was also reported that fragments were generated from the broken wrist fusion plate and were retained in the patient.Procedure was completed successfully without any surgical delay.Patient¿s outcome reported as okay.This report is for one (1) 2.4mm va-lcp dorsal distal rad plate/radial column/6h shaft this is report 1 of 4 for complaint (b)(4).
Additional Manufacturer Narrative
A device history record (dhr) review was performed for part # 02.115.540, lot # 7651200: manufacturing location: (b)(4), release to warehouse date: 31.Oct.2011: no non-conformance reports (ncrs) were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.No product was returned.Us customer quality (cq) conducted the investigation based on x-ray provided.X-ray provided showed no product defect and the complaint of infection/non-union could not be confirmed.Whether this complaint could be replicated is not applicable because the device was not returned.Since no product defect was found, no further investigation will be conducted.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: 2.4MM VA-LCP DORSAL DISTAL RAD PLATE/RADIAL COLUMN/6H SHAFT
• 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: 7083551
• Report Number: 8030965-2017-50301
• Device Sequence Number: 16368808
• Product Code: HRS
• UDI-Device Identifier: 10886982035448
• UDI-Public: (01)10886982035448(10)7651200
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K102694
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/06/2017

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: 02.115.540
• Device Catalogue Number: 02.115.540
• Device Lot Number: 7651200
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/06/2017
• Supplement Date Received by Manufacturer: 01/04/2018
• Initial Report FDA Received Date: 12/05/2017
• Supplement Report FDA Received Date: 01/05/2018
• 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 Weight: 66