MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.5 LCP SUPERIOR CLAV PL/7 HOLE/RT/100; PLATE, FIXATION, BONE

Model Number	02.112.082
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
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 an lcp superior clavicle plate.There was a reoperation due to hardware removal- patient could "feel" plate.There was a known union of fracture after 6 weeks duration and no post-operative complications reported.Patient outcome is unknown.No further information is available.Concomitant devices reported: unk - screws: (part# unknown; lot# unknown; quantity: unknown).This complaint involves nine (9) devices.This report is for (1)3.5 lcp superior clav pl/7 hole/rt/100.This report is 1 of 9 for (b)(4).

• Brand Name: 3.5 LCP SUPERIOR CLAV PL/7 HOLE/RT/100
• 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: 12491408
• Report Number: 2939274-2021-05540
• Device Sequence Number: 3735668
• Product Code: HRS
• UDI-Device Identifier: 10886982033130
• UDI-Public: (01)10886982033130
• 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: health professional,study
• Initial Reporter Occupation: Physician
• 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: 02.112.082
• Device Catalogue Number: 02.112.082
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 20 YR