MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC PERIOSTEAL ELEVATOR 6MM CURVED BLADE-STRAIGHT EDGE

Model Number	399.40
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device used for treatment, not diagnosis.No patient involvement reported.Device is an instrument and is not implanted/explanted.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.(b)(6).(b)(4).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.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 during sterile processing, the brown handles of two (2) periosteal elevator 6mm curved blade-straight edges bled into the tray.This did not occur during surgery and there was no patient involvement.This complaint involves two (2) parts.This report is 1 of 2 for (b)(4).

• Brand Name: PERIOSTEAL ELEVATOR 6MM CURVED BLADE-STRAIGHT EDGE
• Common Device Name: ELEVATOR
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7430198
• Report Number: 2939274-2018-51678
• Device Sequence Number: 19372147
• Product Code: HTE
• UDI-Device Identifier: 10886982202789
• UDI-Public: (01)10886982202789
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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): 03/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 399.40
• Device Catalogue Number: 399.40
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/22/2018
• Initial Report FDA Received Date: 04/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1