MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TREPHINE ATTACHMENT 5.5MM DIAMETER

Model Number	03.111.025
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/25/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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 during an unknown procedure on (b)(6) 2020, the 5.5mm trephine attachment was broken and came off while it was use with the bone harvesting instrument.It is unknown if there was a surgical delay.The procedure was successfully completed.Patient status was good.Concomitant device reported: unknown bone harvesting instrument (part # unknown, lot # unknown, quantity unknown).This complaint involves one (1) device.This report is for one (1) trephine attachment 5.5mm diameter.This is report 1 of 1 for (b)(4).

• Brand Name: TREPHINE ATTACHMENT 5.5MM DIAMETER
• Common Device Name: TREPHINE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10261440
• Report Number: 2939274-2020-03194
• Device Sequence Number: 2623608
• Product Code: HWK
• UDI-Device Identifier: 10886982072245
• UDI-Public: (01)10886982072245
• Combination Product (Y/N): N
• Initial Reporter State: ND
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/26/2020

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: 03.111.025
• Device Catalogue Number: 03.111.025
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/26/2020
• Initial Report FDA Received Date: 07/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1