MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TI LCP(TM) DISTAL RADIUS PLATE VOLAR/LEFT-LONG; PLATE,FIXATION,BONE

Model Number	442.492
Medical Device Problem Code	Bent (1059)
Health Effect - Clinical Codes	Failure of Implant (1924); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional device code: hwc.Device is not expected to be returned for manufacturer review/investigation.Patient code (b)(4) used to capture additional medical/surgical intervention required.Device evaluation/investigation could not be completed; no conclusion could be drawn as product was not returned to manufacturer.Device history records review is pending completion.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 was implanted with a synthes titanium (ti) locking compression plate (lcp) distal radius plate volar/left-long, four (4) unknown 2.4mm ti locking screws, and four (4) unknown 2.4mm titanium cortex screws to treat an unknown radius fracture on an unknown date in 2017.On an unknown date postoperatively, it was identified that the plate had bent and there was a dorsal displacement of the fracture, identified on preoperative x-rays.On (b)(6) 2017, the patient was returned to the operating room where the implants were removed intact and the patient was revised using a different synthes device.Patient outcome was not reported.Concomitant devices reported: 2.4mm ti locking screws (part# unknown, lot# unknown, quantity 4), 2.4mm ti cortex screws (part# unknown, lot# unknown, quantity 4), this report is for one (1) ti lcp(tm) distal radius plate ti lcp(tm) distal radius plate.This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Dhr review was completed.Part no.: 442.492 lot no.: 9123424 manufacturing location: (b)(4).Release to warehouse date: 27.Aug.2014 no 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.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: TI LCP(TM) DISTAL RADIUS PLATE VOLAR/LEFT-LONG
• 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: 7195998
• Report Number: 2939274-2018-50291
• Device Sequence Number: 917937
• Product Code: HRS
• UDI-Device Identifier: 10886982222893
• UDI-Public: (01)10886982222893(10)9123424
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K091644
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 12/19/2017

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?: Yes
• Operator of Device: No Information
• Device Model Number: 442.492
• Device Catalogue Number: 442.492
• Device Lot Number: 9123424
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/19/2017
• Supplement Date Received by Manufacturer: 02/15/2018
• Initial Report FDA Received Date: 01/16/2018
• Supplement Report FDA Received Date: 02/16/2018
• 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