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	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Nonunion/Delayed-union Bone Fracture (2369); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.Patient code (b)(4) used for the patient underwent revision of a spanning wrist plate, one 2.4 locking screw, and seven 2.4 cortex screws on (b)(6) 2018 due to delayed union of the distal radius 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.Based on the information available, this complaint will be accounted for and monitored via post market surveillance activities.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 the patient underwent revision of a spanning wrist plate, one 2.4 locking screw, and seven 2.4 cortex screws on (b)(6) 2018 due to delayed union of the distal radius.The nine devices were removed and a variable angle (va) 2 column plate was inserted along with bone grafting from the iliac crest.The devices were originally implanted on (b)(6) 2017.The surgery was successfully completed with no delay.The patient outcome was reported as ok.This complaint involves three devices.This report is 1 of 3 for (b)(4).
Additional Manufacturer Narrative
Device used for treatment, not diagnosis.Remove expiration date from initial report, reported in error.Investigation summary product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.

• 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: 7430884
• Report Number: 2939274-2018-51698
• Device Sequence Number: 1963686
• Product Code: HRS
• UDI-Device Identifier: 10886982003638
• UDI-Public: (01)10886982003638
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K040588
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• 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): 03/22/2018

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 Expiration Date: 03/22/2018
• Device Model Number: SD242.003
• Device Catalogue Number: SD242.003
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/22/2018
• Supplement Date Received by Manufacturer: 04/19/2018
• Initial Report FDA Received Date: 04/13/2018
• Supplement Report FDA Received Date: 04/19/2018
• 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: 48 YR
• Patient Weight: 65