MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.7MM LCP(TM) PLATE 7 HOLES/67MM; PLATE, FIXATION, BONE

Model Number	249.683
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Failure of Implant (1924); 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).Without a lot number the device history records review could not be completed.Product was not returned.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 the patient underwent hardware removal procedure on an unknown date due to broken 2.7 mm locking compression plate (lcp).The broken locking compression plate and seven (7) intact screws were removed during hardware removal surgery and patient was revised with 2.7/3.5 variable angle (va) olecranon plate and 2.7 lcp plate.Fragments were generated and removed easily without additional intervention.It is unknown if there was surgical delay.Procedure was successfully completed.Patient outcome was unknown.Concomitant devices reported: unk - screws: trauma (part # unknown, lot # unknown, quantity# 7).This report is for one (1) 2.7 mm lcp plate 7 holes/67 mm.This is report 1 of 1 for complaint (b)(4).

• Brand Name: 2.7MM LCP(TM) PLATE 7 HOLES/67MM
• 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: 8649671
• Report Number: 2939274-2019-58358
• Device Sequence Number: 2173103
• Product Code: HRS
• UDI-Device Identifier: 10886982171283
• UDI-Public: (01)10886982171283
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K063049
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/29/2019

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: 249.683
• Device Catalogue Number: 249.683
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/29/2019
• Initial Report FDA Received Date: 05/29/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention