MAUDE Adverse Event Report: DEPUY SPINE INC 6MM DOUBLE-LEAD TAP, CAN; BONE TAP

Catalog Number	299704960
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/08/2023
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.H10 additional narrative: d9: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.H3, h4, h6: without a lot number the device history records review could not be completed.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
Device report from synthes reports an event in australia as follows: it was reported that on (b)(6) 2023, the taps were received in loan set.No adverse event.This report is for one (1) expedium spine system double-lead tap, cannulated 6mm 30-60mm plus or minus 1.67 percent.This is report 1 of 5 for complaint (b)(4).
Event or Problem Description
The initial complaint was reviewed, and the expedium spine system double-lead tap, cannulated 6mm 30-60mm plus or minus 1.67 percent (catalog #299704960) was determined to be not reportable.Upon receipt of additional information from the reporter, it was noted that they did not know the specific product code involved in the event.Reports for four unknown taps are submitted under medwatch report numbers 1526439-2023-01544, 1526439-2023-01546, 1526439-2023-01545, and 1526439-2023-01547.

• Brand Name: 6MM DOUBLE-LEAD TAP, CAN
• Common Device Name: BONE TAP
• 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: 17638597
• Report Number: 1526439-2023-01543
• Device Sequence Number: 7585557
• Product Code: HWX
• UDI-Device Identifier: 10705034467023
• UDI-Public: (01)10705034467023
• 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: 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: 299704960
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/09/2023
• Supplement Date Received by Manufacturer: 08/18/2023
• Initial Report FDA Received Date: 08/28/2023
• Supplement Report FDA Received Date: 08/30/2023
• 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: UNKNOWN TAPS; UNKNOWN TAPS; UNKNOWN TAPS; UNKNOWN TAPS
• Patient Sex: Unknown