MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.5MM TI LCP HOOK PLATE 3 HOLE; PLATE, FIXATION, BONE

Model Number	04.113.103
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.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 (b)(6) 2021, the patient underwent a hardware removal of broken synthes plates and screws.There were eight (8) 2.7mm broken screws and two (2) 3.5mm broken screws.Hardware was successfully removed.Patient outcome is unknown.No further information provided.Concomitant devices reported: 2.7mm/3.5mm ti va-lcp ext medl dhp 4h/lt/111mm-long (part# 04.117.704, lot # unknown, quantity 1), 3.5mm ti lcp® posterolateral distal humerus plate 5h-left (part# 441.265, lot # unknown, quantity 1), 2.7mm screw (part# unknown, lot # unknown, quantity 8), 3.5mm screw (part# unknown, lot # unknown, quantity 2).This report is for one (1) 3.5mm ti lcp hook plate 3 hole.This is report 1 of 10 for (b)(4).This complaint involves total 13 devices.This (b)(4) reports total 10 devices while remaining 3 devices are reported under related (b)(4).

• Brand Name: 3.5MM TI LCP HOOK PLATE 3 HOLE
• 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: 11366759
• Report Number: 2939274-2021-01012
• Device Sequence Number: 11024503
• Product Code: HRS
• UDI-Device Identifier: 10886982104304
• UDI-Public: (01)10886982104304
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K082072
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/01/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 04.113.103
• Device Catalogue Number: 04.113.103
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/01/2021
• Initial Report FDA Received Date: 02/23/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 2.7MM/3.5MM TI VA-LCP EXT MEDL DHP 4H/LT; 3.5MM TI LCP® POSTEROLATERAL DISTAL HUMERUS PL 5H; UNK - SCREWS: TRAUMA (QTY 10)
• Outcome Attributed to Adverse Event: Required Intervention