MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 4.5MM LCP® CONDYLAR PLATE 12 HOLES/278MM-LEFT; PLATE, FIXATION, BONE

Model Number	222.663
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Failure of Implant (1924); Nonunion/Delayed-union Bone Fracture (2369)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient information is not available for reporting.Date of postoperative plate breakage and distal femoral non-union development is unknown.Additional device product codes: hwc, hty, jdw.Implant date is unknown.Device not explanted yet.Complainant device 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 a patient will have to undergo a revision surgery on (b)(6) 2018 for removal of broken 4.5 mm locking compression (lcp) condylar plate 12 holes/278 mm-left and treatment of distal femoral non-union.The patient was implanted with a 4.5 mm lcp condylar plate and a combination of cortex and locking screws for a distal femur fracture on an unknown date.Further it was reported that the patient didn't showed up for the revision surgery scheduled for (b)(6) 2018.It is unknown as of right now that whether and when the revision surgery will take place in the future.Concomitant devices reported: cortex screws (part # unknown, lot # unknown, qty # unknown), locking screws (part # unknown, lot # unknown, qty # unknown).This is report 1 of 1 for (b)(4).

• Brand Name: 4.5MM LCP® CONDYLAR PLATE 12 HOLES/278MM-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: 7296377
• Report Number: 2939274-2018-50789
• Device Sequence Number: 11341350
• Product Code: HRS
• UDI-Device Identifier: 10886982157423
• UDI-Public: (01)10886982157423(10)LOTNUMBERUNKNOWN
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K000066
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 01/29/2018

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: 222.663
• Device Catalogue Number: 222.663
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/29/2018
• Initial Report FDA Received Date: 02/26/2018
• 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