MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.0MM TI Y-PLATE/3 HOLES HEAD 8 HOLES SHAFT/48MM; PLATE, FIXATION, BONE

Model Number	447.612
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	04/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient identifier information unknown.Device broken on an unknown date in (b)(6+) 2018.Lot number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation, and has been discarded.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 a closed wedge osteotomy of proximal first metatarsal of the right foot was performed on (b)(6) 2018.During the procedure, a fixation of bone fragments was achieved with 2.0mm 3x8 hole y plate-titanium and 6 cortex screws from 2.0 modular handset.The surgeon reported no in-operative events or malfunction of the implants or instrumentation used.Prior to implantation the straight portion of the plate had been cut, and the three holes on the end of the plate were removed before being used on the patient.Reportedly, the patient was seen in a post-operative visit two days later and images of the implants showed the plate was broken.It was further explained that the junction between the 3-holed pronged end of the plate and the straight 5-holed portion was broken.All six implanted screws were intact and in the same site visualized in post-operative imaging.When asked if anything had occurred between the initial surgery and the post-operative visit, the patient reported that she had tripped and fell one hour after the initial surgery.The patient will be revised on (b)(6) 2018, when the same implant type/size and new screws will be placed and the two broken plate fragments and six screws will be removed.All available information has been reported.The revision surgery was successfully completed ¿ devices will be retained by the hospital ¿ no x- ray images are available.Concomitant devices reported: cortex screws (part # unknown, lot # unknown, quantity 6).This complaint involves one (one) device.This is report 1 of 1 for pc ¿ (b)(4).

• Brand Name: 2.0MM TI Y-PLATE/3 HOLES HEAD 8 HOLES SHAFT/48MM
• 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: 7515162
• Report Number: 2939274-2018-52170
• Device Sequence Number: 19464576
• Product Code: HRS
• UDI-Device Identifier: 10886982224002
• UDI-Public: (01)10886982224002
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: PRE-AMEND
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 04/23/2018

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: 447.612
• Device Catalogue Number: 447.612
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/23/2018
• Initial Report FDA Received Date: 05/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention