MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.5MM LCP SUP ANT CLAVICLE PL W/LAT EXTN 3H/LT/69MM; PLATE,FIXATION,BONE

Model Number	02.112.007
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.Reporter is a j&j representative.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 for a fracture removal surgery for a shaft fracture utilizing an lcp superior-anterior clavicle plate.There was a union of fracture after 12 weeks duration.1 year postoperatively, hardware removal was reported due to patient could feel the implant.Patient outcome is unknown.No further information is available.Concomitant device reported: unknown screws: cortex (part# unknown; lot# unknown; quantity: 6).This complaint involves seven(7) devices.This report is for (1)3.5mm lcp sup ant clavicle pl w/lat extn 3h/lt/69mm.This report is 1 of 7 for (b)(4).

• Brand Name: 3.5MM LCP SUP ANT CLAVICLE PL W/LAT EXTN 3H/LT/69MM
• 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: 12456498
• Report Number: 2939274-2021-05336
• Device Sequence Number: 3391618
• Product Code: HRS
• UDI-Device Identifier: 10886982032577
• UDI-Public: (01)10886982032577
• 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: Other Health Care Professional
• 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?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 02.112.007
• Device Catalogue Number: 02.112.007
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 37 YR