MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.4MM VA-LCP VOLAR RIM DISTAL RADIUS PLATE/6H HD/5H SHAFT/LT; PLATE, FIXATION, BONE

Model Number	02.115.751
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
Patient information is unknown.It is unknown when patient¿s pain began.Additional procode: hwc.Lot number is unknown.Date of implantation is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter email address is unavailable.Reporter is a synthes sales consultant.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.(b)(4).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) 2018, patient underwent a hardware removal of the variable angle (va) - locking compression plate (lcp) volar rim distal radius dorsal titanium (ti) plate and screws due to pain.There was no additional hardware implanted.The procedure was successfully completed.Patient outcome was not provided.This report is for a 2.4mm va-lcp volar rim distal radius plate 6-hole hd/5-hole shaft/left.This is report 1 of 2 for (b)(4).

• Brand Name: 2.4MM VA-LCP VOLAR RIM DISTAL RADIUS PLATE/6H HD/5H SHAFT/LT
• 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: 7865045
• Report Number: 2939274-2018-53732
• Device Sequence Number: 1941028
• Product Code: HRS
• UDI-Device Identifier: 10886982035561
• UDI-Public: (01)10886982035561
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K110125
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/22/2018

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: 02.115.751
• Device Catalogue Number: 02.115.751
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/22/2018
• Initial Report FDA Received Date: 09/11/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention