MAUDE Adverse Event Report: SYNTHES GMBH 2.5 DRILL BIT QC 135 45 CALIBRATION; BIT, D¬RILL

Model Number	03.133.102
Medical Device Problem Code	Failure to Cut (2587)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/08/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Device available for evaluation: 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 on (b)(6) 2023 the surgeon complained that two of the pointed reduction forceps were dull on the tips.These forceps were tagged as broken to be removed from service.Additionally the surgical tech said that the 2.0 t6 driver was not holding screw good enough.No adverse events occurred and the surgery was successfully completed.No fragments were generated.There was no surgical delay.And no patient outcome.This complaint involves one (1) devices.This report is for one (1) 2.5 drill bit qc 135 45 calibration.This is report 1 of 1 for complaint (b)(4).
Event or Problem Description
The 2.5 drill bit went dull quickly.The patient did have very dense bone.

• Brand Name: 2.5 DRILL BIT QC 135 45 CALIBRATION
• Common Device Name: BIT, D¬RILL
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• 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: 16249916
• Report Number: 8030965-2023-01021
• Device Sequence Number: 20411345
• Product Code: HTW
• UDI-Device Identifier: 10886982269614
• UDI-Public: (01)10886982269614
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup

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: 03.133.102
• Device Catalogue Number: 03.133.102
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/08/2023
• Supplement Date Received by Manufacturer: 01/31/2023
• Initial Report FDA Received Date: 01/26/2023
• Supplement Report FDA Received Date: 02/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 2.5 DRILL BIT QC 135 45 CALIBRATION.; 2.5 DRILL BIT QC 135 45 CALIBRATION.; REDUCTION FORCEPS POINTS SPEED LOCK 205.; REDUCTION FORCEPS POINTS SPEED LOCK 205.
• Patient Age: 38 YR
• Patient Sex: Male