MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.7MM/3.5MM VA-LCP EXT MEDL DSTL HUM PL 4H/RT/111MM-LONG; PLATE, FIXATION, BONE

Model Number	02.117.604
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 age/date of birth, gender and weight are unknown.Date of event: unknown.Additional product code: hwc.Implant date: unknown.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 a patient underwent open reduction internal fixation (orif) right elbow, on an unknown date.The patient presented with a fracture nonunion in the humerus and a broken plate on (b)(6) 2018.The patient was revised to a total elbow after having the following hardware removed: two (2) plates, one (1) olecranon nail, one (1) olecranon end cap, and fourteen (14) screws.All hardware was removed intact except for the medial distal humerus plate which was broken.All hardware was removed with no delays or complications.There are no x-rays.Concomitant device report: 2.7 mm/3.5 mm va-lcp postlat dstl hum pl/4h/rt/88 mm-medium (part 02.117.204, lot unknown, quantity 1), olecranon osteotomy nail (part 02.007.001, lot unknown, quantity 1), olecranon osteotomy end cap (part 02.007.002, lot unknown, quantity 1) and unknown screws (part unknown, lot unknown, quantity 14).This is report 1 of 1 for (b)(4).

• Brand Name: 2.7MM/3.5MM VA-LCP EXT MEDL DSTL HUM PL 4H/RT/111MM-LONG
• 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: 7263367
• Report Number: 2939274-2018-50588
• Device Sequence Number: 1222843
• Product Code: HRS
• UDI-Device Identifier: 10886982037008
• UDI-Public: (01)10886982037008(10)LOTUNKNOWN
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K120070
• 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): 01/19/2018

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: 02.117.604
• Device Catalogue Number: 02.117.604
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/19/2018
• Initial Report FDA Received Date: 02/12/2018
• 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