MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC 4MM FBALL,M; DRILLS, BURRS, TREPHINES AND ACCESSORIES (SIMPLE, POWERED)

Model Number M-4B-G1

Device Problems Break (1069); Separation Problem (4043)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/18/2021

Event Type  malfunction  

Manufacturer Narrative

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 the reported condition that the device was stuck in the attachment device was confirmed.The assignable root cause of this condition was determined to be traced to component failure due to normal wear.A review of the device history record (dhr) was performed which indicated that there were no relevant issues identified during the manufacture of the device that may have contributed to the reported condition.Concomitant med products and therapy dates: attachment device, handpiece device; (b)(6) 2021 udi ¿ (b)(4).

Event Description

It was reported from (b)(6) that during service and evaluation, it was determined that the drill bit device had broken cutting edges and showed clear signs of use.It was further determined that the device failed pretest for visual assessment.It was noted in the service order that during a craniotomy surgical procedure, the attachment device became stuck on the handpiece device with the burr device still inserted.The devices were unable to be removed.It was reported that the medium sleeve slips up the shaft of the attachment device.It was reported that there was a surgical delay of 5 minutes.The procedure was completed as intended with an unknown spare device.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.

• Brand Name: 4MM FBALL,M
• Type of Device: DRILLS, BURRS, TREPHINES AND ACCESSORIES (SIMPLE, POWERED)
• Manufacturer (Section D): DEPUY SYNTHES PRODUCTS LLC; 4500 riverside drive; palm beach gardens FL 33410
• Manufacturer Contact: kara ditty-bovard ; 4500 riverside drive; palm beach gardens, FL 33410 ; 6107428552
• MDR Report Key: 11943978
• MDR Text Key: 258108364
• Report Number: 1045834-2021-00869
• Device Sequence Number: 1
• Product Code: HBE
• UDI-Device Identifier: 00845384012474
• UDI-Public: 00845384012474
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K113476
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M-4B-G1
• Device Catalogue Number: M-4B-G1
• Device Lot Number: P043141432
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2021
• Date Manufacturer Received: 05/18/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/02/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1