MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC 2.3MM FLUTED MATCHSTICK, 15CM; DRILLS, BURRS, TREPHINES & ACCESSORIES - CUTTING BURR

Catalog Number	MA15-8N
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/18/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Reporter's phone number extension: (b)(6).As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.Udi: (b)(4).
Event or Problem Description
It was reported from (b)(6) that during an unspecified surgical procedure it was observed that the tip of the cutter device broke off while in use on the patient.It was reported that the broken piece was detained and the surgical site was inspected with a microscope and no parts of the device remained inside.It was not reported if there were any delays in the procedure due to the event.It was reported that there was an unspecified spare device available for use.There was patient involvement reported.There were no reports of any injuries, medical intervention, or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.
Additional Manufacturer Narrative
This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, 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 this medwatch, a supplemental medwatch report will be filed as appropriate.H10 additional narrative: h6: device history review: as of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.A review of the device history was performed and no non-conformances were detected related to the reported condition.

• Brand Name: 2.3MM FLUTED MATCHSTICK, 15CM
• Common Device Name: DRILLS, BURRS, TREPHINES & ACCESSORIES - CUTTING BURR
• Manufacturer (Section D): DEPUY SYNTHES PRODUCTS LLC; 4500 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 11214422
• Report Number: 1045834-2021-00076
• Device Sequence Number: 14189841
• Product Code: HBE
• UDI-Device Identifier: 00845384004592
• UDI-Public: 845384004592
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K042783
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/08/2021

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 Expiration Date: 01/20/2025
• Device Catalogue Number: MA15-8N
• Device Lot Number: P063141649
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/08/2021
• Supplement Date Received by Manufacturer: 03/31/2021
• Initial Report FDA Received Date: 01/22/2021
• Supplement Report FDA Received Date: 04/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1