MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.5 LCP SUPERIOR CLAV PL/6 HOLE/RT/85; PLATE, FIXATION, BONE

Model Number	02.112.080
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Skin Inflammation/ Irritation (4545)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation could not be completed; no conclusion could be drawn, as no product was received.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.
Event or Problem Description
It was reported that on an unknown date, the patient underwent a fracture fixation for a shaft fracture utilizing a lcp superior clavicle plate.Reoperation was due to hardware removal due to plate irritation reported by the patient.There was a union of fracture in about 12 weeks duration.No postoperative complications reported.Patient outcome is unknown.No further information is available.This report is for one (1) 3.5 lcp superior clav pl/6 hole/rt/85.This is report 1 of 1 for (b)(4).

• Brand Name: 3.5 LCP SUPERIOR CLAV PL/6 HOLE/RT/85
• 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: 12489229
• Report Number: 2939274-2021-05526
• Device Sequence Number: 3735660
• Product Code: HRS
• UDI-Device Identifier: 10886982033093
• UDI-Public: (01)10886982033093
• 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: company representative,study
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/23/2021

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: 02.112.080
• Device Catalogue Number: 02.112.080
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/23/2021
• Initial Report FDA Received Date: 09/17/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - SCREWS: CORTEX
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 11 YR