MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.8MM CALIBRATED DRILL BIT QC 250MM/95MM; BIT, DRILL

Model Number	03.113.024
Medical Device Problem Codes	Overheating of Device (1437); Failure to Cut (2587)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/25/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Additional narrative: without a valid lot number the device history records review could not be completed.Complainant device is not expected to be returned for manufacturer review/investigation.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 on an unknown procedure that locking screw did not engage with one of the combo holes in the plate.A non-locking screw was used in its place.The locking screw was found not be the problem as the same screw engaged a different locking hole.Two new drill bits were also found to be dull and heated up the bone excessively when trying to drill with them.No surgical delay and patient consequence.This complaint involves 3 device.This report is for one (1) 2.8mm calibrated drill bit qc 250mm/95mm.This report is 2 of 3 for (b)(4).

• Brand Name: 2.8MM CALIBRATED DRILL BIT QC 250MM/95MM
• 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: 12029014
• Report Number: 2939274-2021-03072
• Device Sequence Number: 4354194
• Product Code: HTW
• UDI-Device Identifier: 10886982072900
• UDI-Public: (01)10886982072900
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/26/2021

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: 03.113.024
• Device Catalogue Number: 03.113.024
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/26/2021
• Initial Report FDA Received Date: 06/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1