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	Not Applicable (3189); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device used for treatment, not diagnosis.Patient age not provided for reporting.Date of event: unknown.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(6).(b)(4).The investigation could not be completed; no conclusion could be drawn, as no product was received.Device history records review not available to report at this time., based on the information available, this complaint will be accounted for and monitored via post market surveillance activities.If additional is obtained that was not available for the initial med-watch, the investigation will be updated as applicable, and a follow-up med-watch will be filed as appropriate.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 hardware removal was performed on (b)(6) 2018 due to a broken wrist-spanning plate.The original procedure was performed on (b)(6) 2016 following a roll-over motor vehicle accident.The removed hardware included: one plate, six 2.4 mm cortex screws and two 2.4 mm locking screws, all removed successfully.This complaint involves nine (9) devices.Concomitant devices: 2.4 mm cortex screws (part #: unk, lot #: unk, qty: 6), 2.4 mm locking screws (part #: unk, lot #: unk, qty: 2).

• 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: 7412718
• Report Number: 2939274-2018-51560
• Device Sequence Number: 931370
• Product Code: HRS
• UDI-Device Identifier: 10886982003638
• UDI-Public: (01)10886982003638(10)9888747
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K040588
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 03/14/2018

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/14/2018
• Device Model Number: SD242.003
• Device Catalogue Number: SD242.003
• Device Lot Number: 9888747
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/14/2018
• Initial Report FDA Received Date: 04/10/2018
• 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 Weight: 90