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

Model Number	442.491
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Discomfort (2330)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device was used for treatment, not diagnosis.Lot number is unknown.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.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 could feel one (1) previously implanted locking compression plate (lcp) distal radius volar plate under their skin and it bothered them.The patient clarified that they did not feel any pain.Subsequently, on (b)(6) 2018, the patient underwent removal of the entire construct consisting of one (1) lcp distal radius volar plate and six (6) unknown locking screws.All devices were removed intact and the patient was not revised to any other implants.The hardware removal was reported to have been completed successfully.This complaint is for one (1) lcp distal radius volar plate (part number 442.491, lot number unknown, quantity 1).Concomitant devices reported: locking screws (part number unknown, lot number unknown, quantity 6).This is report 1 of 1 for (b)(4).

• Brand Name: TI LCP(TM) DISTAL RADIUS PLATE VOLAR/LEFT-SHORT
• 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: 7615117
• Report Number: 2939274-2018-52546
• Device Sequence Number: 2142125
• Product Code: HRS
• UDI-Device Identifier: 10886982222886
• UDI-Public: (01)10886982222886
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K091644
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 05/25/2018

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: 442.491
• Device Catalogue Number: 442.491
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/25/2018
• Initial Report FDA Received Date: 06/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 31 YR
• Patient Weight: 72