MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 13.0MM FLEXIBLE CANNULATED DRILL BIT LARGE QC/465MM; BIT, DRILL

Model Number	03.010.034
Medical Device Problem Code	Failure to Cut (2587)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/08/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.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
Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2022, the four (4) 13mm drill bits from the rafn sets are dull and require sharpening.There was no patient consequence.This report involves one (1) 13.0mm flexible cannulated drill bit large qc/465mm.This is report 3 of 4 for (b)(4).

• Brand Name: 13.0MM FLEXIBLE CANNULATED DRILL BIT LARGE QC/465MM
• Common Device Name: BIT, DRILL
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 14027256
• Report Number: 2939274-2022-01222
• Device Sequence Number: 6056833
• Product Code: HTW
• UDI-Device Identifier: 10886982067067
• UDI-Public: (01)10886982067067
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

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: 03.010.034
• Device Catalogue Number: 03.010.034
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/08/2022
• Initial Report FDA Received Date: 04/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 13.0 FLEXIBLE CANN DRILL BIT LRG QC/465; 13.0MM CANNULATED DRILL BIT 300MM; 13.0MM CANNULATED DRILL BIT 300MM
• Patient Sex: Unknown