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	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/07/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Udi: lot/serial unknown.(b)(4).Device manufacture date: the device manufacture date is unavailable.As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.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 from canada that during an unspecified surgical procedure of the spine it was observed that the tip of the burr device broke off during use after five minutes.It was reported that the user was able to retrieve the tip of the device from the patient.It was not reported if there was a delay in the procedure due to the event.It was not reported if there was a spare device available for use.There was patient involvement reported.There were no reports of injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.
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.The actual device was returned for evaluation.Quality engineering evaluated the cutter device and it was determined that the device had a broken tip.An assessment was performed and it was determined that the external features of the returned cutter were visually inspected and observed that the tip of the cutter was broken.The cutter was examined with 28x magnification.It was determined that based on the photographs taken, the angle indicated that there was excessive force applied.Therefore, the reported condition was confirmed.The root cause of the customer¿s complaint that ¿cutters broke¿ was excessive lateral or side to side force.The assignable root cause of this condition was determined to be traced to user error.If additional information should become available, a supplemental medwatch report will be submitted accordingly.
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.Concomitant med products: bearing sleeve device.Additional narrative: the actual device has been returned and is currently pending evaluation.Once the evaluation of the device has been completed, a supplemental medwatch report will be sent accordingly.Additionally, a concomitant device has been added to the complaint.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.Additional narrative: additional information: d4: please note that the lot number was documented as unknown in the initial medwatch report.The lot number (n153136794) has been documented in section of this medwatch report.It was documented in the initial medwatch report that the date of manufacture (dom) was unknown.The dom (b)(6) 2019) has been updated to reflect the date the device was manufactured.The unique identifier (udi) has been updated accordingly.If additional information should become available, a supplemental medwatch report will be submitted accordingly.Udi: (b)(4).

• 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: 9215789
• Report Number: 1045834-2019-54732
• Device Sequence Number: 13555696
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/08/2019

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: MA15-8N
• Device Lot Number: N153136794
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2019
• Initial Date Received by Manufacturer: 10/08/2019
• Supplement Date Received by Manufacturer: 11/12/2019; 12/19/2019; 01/07/2020
• Initial Report FDA Received Date: 10/21/2019
• Supplement Report FDA Received Date: 12/03/2019; 12/26/2019; 01/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1