MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC QUARTER-TUBULAR PL COLLAR 6 HOLES/47; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, SINGLE COMPONENT

Model Number	242.06
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Nonunion/Delayed-union Bone Fracture (2369)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2021, the patient underwent revision fixation and bone grafting.Patient has an open reduction of the right bone mid-shift ulna and radius fracture.The surgery was on (b)(6) 2021.They were fixed with a six hole one-third tubular plate on the radius and a six hole on the ulna.The ulna went on onto a nonunion and the plate broke at the fracture site.The patient returns to the operating room on (b)(6) 2021, for revision fixation and bone grafting.The broken plate and screw were removed from the ulna with no difficulty.All hardware was removed.Only the plate was broken and 5 of the 2.7 mm cortex screws were removed.Fracture site was cleaned up and bone grafted and a new plate and screw were implanted.Concomitant devices reported: unknown screws (part# unknown, lot# unknown, quantity unknown) unknown cortex screws (part# unknown, lot# unknown, quantity unknown).This report is for one (1) quarter-tubular pl collar 6 holes/47.This is report 1 of 1 for complaint (b)(4).
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a j&j field service engineer.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.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.

• Brand Name: QUARTER-TUBULAR PL COLLAR 6 HOLES/47
• Common Device Name: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, SINGLE COMPONENT
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): ELMIRA; 35 airport road; horseheads NY 14845
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12820104
• Report Number: 2939274-2021-06706
• Device Sequence Number: 12202629
• Product Code: KTW
• UDI-Device Identifier: 10886982167873
• UDI-Public: (01)10886982167873
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K010321
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/22/2021

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: 242.06
• Device Catalogue Number: 242.06
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/22/2021
• Initial Report FDA Received Date: 11/16/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - SCREWS: CORTEX; UNK - SCREWS: TRAUMA
• Patient Sex: Female