MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.5MM THREE-FLUTED DRILL BIT QC/110MM; BIT,DRILL

Model Number	315.25
Medical Device Problem Code	Failure to Cut (2587)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a j&j sales representative.A device history record (dhr) review was conducted: part: 315.250-us, lot: 32p1441, manufacturing site: (b)(4), release to warehouse date: 17 january 2020.A manufacturing record evaluation was performed for the finished device part:315.250-us, lot: 32p1441, and no non-conformances were identified.The investigation could not be completed; no conclusion could be drawn, as no product was received.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.
Event or Problem Description
It was reported that on an unknown date during an unknown procedure, the three (3) 2.5 mm three-fluted drill bits were dull.The patient had a hard bone.It is unknown if there was a surgical delay.Procedure and patient outcome is unknown.This report is for one (1) 2.5 mm three-fluted drill bit qc/110 mm.This is report 1 of 3 for (b)(4).

• Brand Name: 2.5MM THREE-FLUTED DRILL BIT QC/110MM
• Common Device Name: BIT,DRILL
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10529986
• Report Number: 2939274-2020-04114
• Device Sequence Number: 19596905
• Product Code: HTW
• UDI-Device Identifier: 10886982189196
• UDI-Public: (01)10886982189196
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 315.25
• Device Catalogue Number: 315.25
• Device Lot Number: 32P1441
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/17/2020
• Initial Report FDA Received Date: 09/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1