MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.5MM LCP PLATE 10 HOLES 137MM; PLATE, FIXATION, BONE

Model Number	223.601
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).Additional pro-code: hwc, ktt.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.(b)(4).Without a lot number, the device history records review could not be completed as no product was received.Investigation summary product was not returned.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 had a one (1) 3.5mm locking compression plate with 10 holes and eight (8) screws implanted on a primary surgery for a midshaft humerus fracture.The patient presented after a fall with a bent plate.The plate did not break and the screws did not pull out.The patient told the surgeon the hardware had failed and threatened litigation.Patient status and outcome were unknown.Concomitant device reported: unknown screws (part#: unknown, lot#: unknown, quantity: 8).This complaint involves one (1) device.This report is 1 of 1 for (b)(4).

• Brand Name: 3.5MM LCP PLATE 10 HOLES 137MM
• 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: 9566862
• Report Number: 2939274-2020-00101
• Device Sequence Number: 2866302
• Product Code: HRS
• UDI-Device Identifier: 10886982157997
• UDI-Public: (01)10886982157997
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K082807
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/12/2019

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: 223.601
• Device Catalogue Number: 223.601
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/12/2019
• Initial Report FDA Received Date: 01/08/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 55 YR
• Patient Weight: 102