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 Code	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.Without a lot number the device history records review could not be completed.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.(b)(4).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 on (b)(6) 2019, the patient underwent removal of a broken 2.4mm locking compression plate straight wrist plate due to non-compliant patient.The plate was removed without complications.There was no additional hardware was put in.The patient¿s distal radius appeared to be healed.The patients broken plate was removed, but they did not need revision surgery.There was no patient consequence.Concomitant device reported: unknown screws: trauma (part # unknown, lot # unknown, quantity# unknown).This complaint involves one (1) device.This is 1 of 1 for report (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: 9317518
• Report Number: 2939274-2019-62149
• Device Sequence Number: 2131294
• Product Code: HRS
• UDI-Device Identifier: 10886982003638
• UDI-Public: (01)10886982003638
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 10/28/2019

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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/28/2019
• Initial Report FDA Received Date: 11/13/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention