MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC LCP DIA-META VOLAR DISTAL RADIUS PL 7H SHAFT/RT; PLATE, FIXATION, BONE

Model Number	02.110.007
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient case# reported as (b)(6).Date of pain is unknown.Date of implantation is unknown.Complainant part 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.A device history records review has been requested.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, the patient had a painful hardware removal of the wrist.It was unknown why the patient wanted the hardware out other than it was painful.There were eight (8) unknown screws, four (4) unknown locking screws, four (4) unknown cortex screws and a dia-meta volar distal radius plate that were removed intact.The procedure was completed successfully with was no surgical delay.Patient outcome is unknown.This report is for a lcp dia-meta volar distal radius pl 7h shaft/rt.This is report 1 of 4 for (b)(4).
Additional Manufacturer Narrative
Device history record (dhr) review: part number: 02.110.007; lot number: h670482; part manufacture date: n/a; manufacturing location: n/a; part expiration date: n/a; nonconformance noted: n/a; dhr record review: a review of the device history record could not be performed as the product was not returned and the lot number provided is not valid for (b)(4).A review of the device history record could not be performed as the product was not returned and the lot number provided is not valid for elmira.Corrected data: event description was updated/corrected.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
Update: it was reported that the plate was intact.The fracture had healed and no further surgeries were required.

• Brand Name: LCP DIA-META VOLAR DISTAL RADIUS PL 7H SHAFT/RT
• 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: 7542166
• Report Number: 2939274-2018-52302
• Device Sequence Number: 19109628
• Product Code: HRS
• UDI-Device Identifier: 10886982030191
• UDI-Public: (01)10886982030191
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K070946
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/07/2018

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: 02.110.007
• Device Catalogue Number: 02.110.007
• Device Lot Number: H670482
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/07/2018
• Supplement Date Received by Manufacturer: 06/20/2018
• Initial Report FDA Received Date: 05/24/2018
• Supplement Report FDA Received Date: 06/26/2018
• 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 Age: 55 YR
• Patient Weight: 89