MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.5MM LCP SUP ANT CLAVICLE PL W/LAT EXTN 4H/RT/81MM; PLATE,FIXATION,BONE

Model Number	02.112.010
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).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 as no product was received.The investigation could not be completed, no conclusion could be drawn at the time of filing this report.The product was not returned.Based on the information available, it has been determined that no corrective and 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.
Event or Problem Description
It was reported that on an unknown date, the patient underwent a fracture fixation surgery for a shaft fracture utilizing a va-lcp anterior plate.There was a union of fracture after12 weeks duration and reported post-operative complication was prolonged pain.Patient outcome is unknown.No further information is available.Concomitant device reported: unk - screw: (part# unknown; lot# unknown; quantity: 10).This complaint involves eleven (11) devices.This report is for (1)3.5mm lcp sup ant clavicle pl w/lat extn 4h/rt/81mm.This report is 1 of 11 for (b)(4).

• Brand Name: 3.5MM LCP SUP ANT CLAVICLE PL W/LAT EXTN 4H/RT/81MM
• 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: 12455343
• Report Number: 2939274-2021-05316
• Device Sequence Number: 3391615
• Product Code: HRS
• UDI-Device Identifier: 10886982032638
• UDI-Public: (01)10886982032638
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K111540
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: study
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 02.112.010
• Device Catalogue Number: 02.112.010
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/13/2021
• Initial Report FDA Received Date: 09/10/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - SCREWS: CORTEX; UNK - SCREWS: CORTEX; UNK - SCREWS: CORTEX; UNK - SCREWS: CORTEX; UNK - SCREWS: CORTEX; UNK - SCREWS: CORTEX; UNK - SCREWS: CORTEX; UNK - SCREWS: CORTEX; UNK - SCREWS: CORTEX; UNK - SCREWS: CORTEX
• Patient Age: 74 YR