MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.4/2.7MM VA-LCP FIRST MTP FUSION PL/SM/5 DEG/LEFT; PLATE, FIXATION, BONE

Model Number	02.211.233
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient information is not available for reporting.Date of postoperative plate breakage is unknown.Additional device product code: hwc.Implanted approximately eighteen (18) months from (b)(6) 2018.It is unknown if the device has been explanted yet.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.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 the patient complained of pain in great toe from an unknown side during a surgeon¿s visit on (b)(6) 2018.Patient was approximately eighteen (18) months out from first metatarsophalangeal joint (mpj) fusion surgery.X-ray revealed broken first (mpj) 5 degree variable angle locking compression plate (va lcp) first mtp fusion plate at the joint line of the great toe.Surgeon mentioned of a possible re-operation.No other information provided.Concomitant device reported: unknown screw (part #: unknown, lot #: unknown, quantity: unknown).This is report 1 of 1 for complaint (b)(4).

• Brand Name: 2.4/2.7MM VA-LCP FIRST MTP FUSION PL/SM/5 DEG/LEFT
• 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: 7778112
• Report Number: 2939274-2018-53301
• Device Sequence Number: 19103694
• Product Code: HRS
• UDI-Device Identifier: 10886982054166
• UDI-Public: (01)10886982054166
• Combination Product (Y/N): N
• Initial Reporter State: SD
• Initial Reporter Country: US
• PMA/510(K) Number: K100776
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/26/2018

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: 02.211.233
• Device Catalogue Number: 02.211.233
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/26/2018
• Initial Report FDA Received Date: 08/13/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention