MAUDE Adverse Event Report: DEPUY SPINE INC MODIFIED INSTRUMENT DRILL,SHORT 16MM; BIT, DRILL

Catalog Number	698344848
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/04/2024
Type of Reportable Event	Malfunction
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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H11 additional narrative: d9: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.H3, h6: 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.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) 2024, there was c3-5 acdf with coda implant system.The drill bit was used with a double barrel dts guide and rubs against the drill bit, shedding small metal pieces.The pieces were removed with a suction and no patient event at that time.The double barrel dts guides are being removed from the hospital.The design of the guides allows flexing while the drill was being used, which caused shedding from the drill bit.It is unknown if the procedure was completed successfully.There was no patient consequences.This report involves one (1) modified instrument drill,short 16mm.This is report 4 of 8 for (b)(4).This complaint is related to (b)(4), which captures additional impacted products.
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.H11 additional narrative: h3, h4, h6: part : 698344848 lot : 441831 batch: dp49979 manufacturing site: gdc raynham supplier: (b)(4) batch1: lot qty of (b)(4) units were released on with no 20 sep, 2023 discrepancies.No ncrs were generated during production.The ri identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer.Product was not returned.Based on the information available, it has been determined that no corrective and 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.H6 component code: g07002 (appropriate term/code not available) used to capture no findings available due to no product returned.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: MODIFIED INSTRUMENT DRILL,SHORT 16MM
• Common Device Name: BIT, DRILL
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA 02767 ; 3035526892
• MDR Report Key: 19372519
• Report Number: 1526439-2024-01553
• Device Sequence Number: 15335502
• Product Code: HTW
• UDI-Device Identifier: 10705034575155
• UDI-Public: 10705034575155
• Combination Product (Y/N): N
• Initial Reporter State: ND
• 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,Company Representative
• 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 Catalogue Number: 698344848
• Device Lot Number: DP49979
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/25/2024
• Supplement Date Received by Manufacturer: 06/21/2024
• Initial Report FDA Received Date: 05/22/2024
• Supplement Report FDA Received Date: 06/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/20/2023
• 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: DBL DTS GUIDE END HOLES; DBL DTS GUIDE INTERMED HOLES; MOD 12MM DRILL, SHORT; MOD 14MM DRILL, SHORT; MOD 16MM DRILL, SHORT; MOD 18MM DRILL, SHORT; MOD DOUBLE BARREL DRILL GUIDE ASSY; MOD DOUBLE BARREL DRILL GUIDE ASSY, INT; MOD DOUBLE BARREL DRILL GUIDE ASSY, INT
• Patient Sex: Unknown