MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.4MM LCP® STRAIGHT WRIST PLATE 170MM; PLATE,FIXATION,BONE

Model Number	SD242.003
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Nonunion/Delayed-union Bone Fracture (2369); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event is unknown.Date of implant is unknown.Device is not expected to be returned for manufacturer review/investigation.(b)(4).Device evaluation/investigation could not be completed; no conclusion could be drawn as product was not returned to manufacturer.Device history records review could not be completed without lot number.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 on an unknown date, patient underwent surgery for open reduction internal fixation (orif) of the distal radius.Subsequently it was discovered that the plate was broken and there was a non-union.A hardware removal and revision of the wrist was performed on (b)(6) 2017 due to a broken plate and non-union.Removed hardware included: the broken plate, and eleven intact screws -all removed without incident.The patient was revised to an identical plate, screws and bone grafting.There were no reported surgical delays, no fragments involved, no additional medical intervention and no additional x-rays required.The procedure was completed successfully with the patient in stable condition.Concomitant device reported: cortex screws (part# unknown, lot# unknown, quantity 3), locking screws (part# unknown, lot# unknown, quantity 8).This report is for one (1) 2.4mm lcp straight wrist plate 170mm.(b)(4).

• Brand Name: 2.4MM LCP® STRAIGHT WRIST PLATE 170MM
• 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: 7125496
• Report Number: 2939274-2017-50345
• Device Sequence Number: 1210663
• Product Code: HRS
• UDI-Device Identifier: 10886982003638
• UDI-Public: (01)10886982003638(10)LOT#UNKNOWN
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K040588
• 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
• Report Date (Section B): 11/20/2017

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: Health Professional
• Device Model Number: SD242.003
• Device Catalogue Number: SD242.003
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/20/2017
• Initial Report FDA Received Date: 12/18/2017
• 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: 47 YR