MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.7MM LCP ULNA OSTEOTOMY PLATE 8 HOLES; PLATE,FIXATION,BONE

Model Number	02.111.901
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¿s gender is unknown.Date of event: date of postoperative nonunion development and plate breakage is unknown.Additional device product code: hwc.Implanted date: implanted in (b)(6) 2017; exact date is unknown.Explanted date: unknown.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 patient underwent an ulnar shortening procedure in (b)(6) 2017.Post-operatively patient had non-union and a plate broke in patient.Future revision surgery plan is unknown.Concomitant devices reported: 2.7mm locking screw slf-tpng with t8 stardrive recess 16mm (part # 202.216, lot # unknown, quantity 6).This report is for one (1) 2.7mm lcp ulna osteotomy plate 8 holes.This is report 1 of 1 for complaint (b)(4).

• Brand Name: 2.7MM LCP ULNA OSTEOTOMY PLATE 8 HOLES
• 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: 7176667
• Report Number: 2939274-2018-50143
• Device Sequence Number: 11262876
• Product Code: HRS
• UDI-Device Identifier: 10886982032478
• UDI-Public: (01)10886982032478(10)LOTNUMBERUNKNOWN
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K113364
• 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): 12/12/2017

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: 02.111.901
• Device Catalogue Number: 02.111.901
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/12/2017
• Initial Report FDA Received Date: 01/09/2018
• 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
• Patient Age: 46 YR
• Patient Weight: 118