MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC MAXFRAME(TM) FULL RING 180MM ALUMINUM; APPLIANCE,FIXATION,NAIL

Model Number	03.312.180
Medical Device Problem Codes	Break (1069); Crack (1135)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device was not explanted.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.Patient code (b)(4)-no code available used to capture need for additional intervention 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 patient was implanted with the maxframe full ring 180mm on unknown date.It was noted on unknown date that the device had cracked.Surgeon used a distraction osteogenesis (do) system and attached a do half ring to the broken maxframe full ring via five (5) threaded rods and twenty (20) nuts.The half ring spanned the crack in the maxframe full ring to provide stability to the frame.The entire frame will be removed as previously scheduled.This report is for one (1) maxframe full ring 180mm this is report 1 of 1 for (b)(4).

• Brand Name: MAXFRAME(TM) FULL RING 180MM ALUMINUM
• Common Device Name: APPLIANCE,FIXATION,NAIL
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7501318
• Report Number: 2939274-2018-52123
• Device Sequence Number: 14002228
• Product Code: KTT
• UDI-Device Identifier: 10886982260826
• UDI-Public: (01)10886982260826
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K161417
• 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): 02/14/2018

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: 03.312.180
• Device Catalogue Number: 03.312.180
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/14/2018
• Initial Report FDA Received Date: 05/09/2018
• 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: 34 YR