MAUDE Adverse Event Report: SYNTHES GMBH 4.2MM THREE-FLUTED DRILL BIT QC/NEEDLE POINT/145MM; BIT, DRILL

Catalog Number	03.010.104
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/08/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Device report from synthes reports an event in australia as follows: it was reported on (b)(6) 2023, that a loan tfna set was found to have bone contaminants in the drill bits during checking in by cssd.Patient status/ outcome / consequences :no.This report is for one (1) unk - drill bits: trauma.This is report 1 of 1 for complaint (b)(4).
Additional Manufacturer Narrative
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.D1, d2, d3, d4, g4-510k: this report is for an unknown drill bit/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k number is unknown.E3: reporter is a j&j sales representative.D9: complainant part is not expected to be returned for manufacturer review/investigation.E3: reporter is a j&j sales representative.H3, h4, h6: 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.
Additional Manufacturer Narrative
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 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.
Additional Manufacturer Narrative
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.Photo investigation: the product was not returned to depuy synthes, however photos were provided for review.The photo investigation revealed that the tip of the drill bit ø4.2 calibr had a foreign substance, no other finding is seen based on the photo.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was confirmed as the observed condition of the device would contribute to the complained device issue.Based on the investigation findings, without the physical device a potential cause cannot be established and it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history: the device lot number is unknown, therefore a device history review could not be performed.If the lot/serial number becomes available, the record will be re-assessed.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.

• Brand Name: 4.2MM THREE-FLUTED DRILL BIT QC/NEEDLE POINT/145MM
• Common Device Name: BIT, DRILL
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 18741001
• Report Number: 8030965-2024-02652
• Device Sequence Number: 12573438
• Product Code: HTW
• UDI-Device Identifier: 10886982067746
• UDI-Public: (01)10886982067746
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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,Followup,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 Catalogue Number: 03.010.104
• 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: 02/08/2024
• Supplement Date Received by Manufacturer: 02/28/2024; 05/08/2024
• Initial Report FDA Received Date: 02/20/2024
• Supplement Report FDA Received Date: 03/01/2024; 05/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - KITS/SETS
• Patient Sex: Unknown