MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC 2.5MM X 25.4MM FRTR,L; MOTOR, DRILL, ELECTRIC - CUTTING BURR

Catalog Number	L-CRN-G1
Medical Device Problem Code	Dull, Blunt (2407)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/28/2020
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.Concomitant med products and therapy dates: attachment device, handpiece device ((b)(6) 2020).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 of the skull it was observed that the cutter device (router) was dull and had poor sharpness, causing the attachment device and handpiece device to generate heat.According to the reporter, the user changed to a new cutter device and the sharpness of the new cutter device was not an issue, and the attachment device and handpiece device did not generate heat.It was further reported that the cutter device (router) had some abnormality.It was reported that there was no allegation against the attachment device and handpiece device.It was reported that there was a twenty minute delay in the procedure due to the event.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
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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.H10 additional narrative: d10, h3, h6: the actual device has been returned and is currently pending evaluation.Once the investigation has been completed, a supplemental medwatch report will be submitted accordingly.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.H10 additional narrative: the actual device was returned for evaluation.Quality engineering evaluated the cutter device and the reported condition that the cutter device (router) was dull and had poor sharpness, causing the attachment device and handpiece device to generate heat was confirmed.An assessment was performed and it was noted that the fluted router was received in heavily used condition.The edges of the device were dull, the front showed some damage, and all over the cutter rust and residues were detected.It was determined that due to detected residues and rust on the product it was very likely the device was reused and reprocessed.The assignable root cause was determined to be traced to user, which is user error.A review of the device history was performed and no non-conformances were detected related to the reported condition.

• Brand Name: 2.5MM X 25.4MM FRTR,L
• Common Device Name: MOTOR, DRILL, ELECTRIC - CUTTING BURR
• Manufacturer (Section D): DEPUY SYNTHES PRODUCTS LLC; 4500 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 10387908
• Report Number: 1045834-2020-01304
• Device Sequence Number: 11624756
• Product Code: HBC
• UDI-Device Identifier: 00845384012856
• UDI-Public: 845384012856
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K113476
• 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
• Report Date (Section B): 07/28/2020

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: 11/30/2023
• Device Catalogue Number: L-CRN-G1
• Device Lot Number: M483134584
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2020
• Initial Date Received by Manufacturer: 07/28/2020
• Supplement Date Received by Manufacturer: 08/17/2020; 09/14/2020
• Initial Report FDA Received Date: 08/10/2020
• Supplement Report FDA Received Date: 09/02/2020; 09/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1