MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC 1.55MM X 10MM TWIST DR,S; DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)

Catalog Number S-1510TD-G1

Device Problems Break (1069); Excessive Heating (4030)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/20/2020

Event Type  malfunction  

Manufacturer Narrative

Concomitant med products and therapy dates: cutter 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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).

Event Description

This is report 2 of 2 for the same event: it was reported from (b)(6) that during an unspecified surgical procedure it was observed that the tip of two cutter devices were burned and damaged.It was not reported if there were any delays 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 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.

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.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.The actual device was returned for evaluation.Quality engineering evaluated the cutter device and it was determined that the reported condition that the device had its tip burned and broken was confirmed.The external features of the returned cutter were visually inspected.There was black discoloration on the tip which indicates insufficient irrigation during the procedure contrary to the directions for use (dfu).The broken cutter was examined and photographed using 40x magnification.Based on the photographs taken the angle indicate that there was excessive force applied.The root cause of the customer¿s complaint that ¿cutters broken and burned¿ was due to excessive lateral or side to side force and lack of irrigation.The operating manual states: do not force the cutting burrs while performing operation.Use a gentle tapping motion or side to side motion and let the instrument do the cutting.Forceful side loading of cutting burrs may cause fracture of dissecting tool, which may cause injury.The assignable root cause was determined to be traced to user, which is user error.

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.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: additional information received from the affiliate states that the device broke.No additional information was provided.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.

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.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.Correction: d10: the date returned to manufacturer was documented as march 20, 2020 on the previous supplemental medwatch report.This date has been updated to march 24, 2020.

• Brand Name: 1.55MM X 10MM TWIST DR,S
• Type of Device: DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)
• Manufacturer (Section D): DEPUY SYNTHES PRODUCTS LLC; 4500 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 9785794
• MDR Text Key: 194971510
• Report Number: 1045834-2020-00382
• Device Sequence Number: 1
• Product Code: HBE
• UDI-Device Identifier: 00845384012610
• UDI-Public: 845384012610
• Combination Product (y/n): N
• PMA/PMN Number: K113476
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/24/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 02/25/2024
• Device Catalogue Number: S-1510TD-G1
• Device Lot Number: N123136399
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2020
• Initial Date Manufacturer Received: 02/24/2020
• Initial Date FDA Received: 03/04/2020
• Supplement Dates Manufacturer Received: 03/20/2020; 03/24/2020; 04/08/2020
• Supplement Dates FDA Received: 03/25/2020; 04/01/2020; 04/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1