MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.4MM VA-LCP 2-CLMN VLR DSTL RADIUS PL 7H HD/3H SHAFT/RIGHT; PLATE, FIXATION ,BONE

Model Number	02.111.730
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Reporter is a synthes employee.Complainant part is not expected to be returned for manufacturer review / investigation.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 on (b)(6) 2019 the patient underwent a hardware removal surgery due to pain.One (1) variable angle (va) locking compression plate (lcp) distal radius plate, six (6) unknown locking screws and three (3) unknown cortex screws were removed.The distal radius plate removed from the right radius contained three (3) 2.7 mm cortex screws and six (6) 2.4 mm va locking screws.While the surgeon was removing the distal locking screws, one of the heads sheared off.The rest of the screws and the plate were removed without incident.Once we were able to see the shaft of the screw the surgeon saw it was flush with the volar cortex.He used a small curette to expose the shaft of the screw and a heavy needle driver to grab and remove the shaft of the screw.There was a surgical delay of 5 minutes.The surgery was completed with no adverse consequence to the patient.This complaint involves ten (10) devices.This report is for one (1) 2.4 mm va-lcp 2-clmn vlr dstl radius pl 7h hd / 3h shaft / right.(b)(4).

• Brand Name: 2.4MM VA-LCP 2-CLMN VLR DSTL RADIUS PL 7H HD/3H SHAFT/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: 9171668
• Report Number: 2939274-2019-61330
• Device Sequence Number: 2402283
• Product Code: HRS
• UDI-Device Identifier: 10886982032294
• UDI-Public: (01)10886982032294
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K063049
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/19/2019

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?: No
• Operator of Device: Health Professional
• Device Model Number: 02.111.730
• Device Catalogue Number: 02.111.730
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/19/2019
• Initial Report FDA Received Date: 10/09/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention