MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC 1.4MM X 12.8MM FRTR,S; DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)

Model Number	S-1R-G1
Medical Device Problem Codes	Material Fragmentation (1261); Dull, Blunt (2407); Separation Problem (4043)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/07/2021
Type of Reportable Event	Malfunction
Additional 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.Additional narrative:: concomitant med products and therapy dates: attachment device, (b)(6) 2021.Device history review: a device history review 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.Device evaluation: the actual device was returned for evaluation.During repair, an evaluation was performed and it was determined that the reported condition was confirmed.The assignable root cause was determined to be traced to user and component damage from normal wear.Udi: (b)(4).
Event or Problem Description
It was reported by (b)(6) that during service and evaluation, it was determined that the bur device failed visual inspection.It was determined that the bur device was stuck inside the attachment device but could be released.It was further determined that the bur device showed heavy signs of usage mostly along the shaft, discoloration was verified and the cutting edge was used up.It was observed that the back end of the bur device used for locking inside the handpiece was missing.It was noted in the service order that the cutting burr device was unable to be removed from the attachment device and the attachment device had an overheating issue.This event did not occur during surgery.There was no patient involvement.There were no reports of injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should available, a supplemental medwatch will be submitted accordingly.

• Brand Name: 1.4MM X 12.8MM FRTR,S
• Common Device Name: DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)
• Manufacturer (Section D): DEPUY SYNTHES PRODUCTS LLC; 4500 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 11995923
• Report Number: 1045834-2021-00936
• Device Sequence Number: 13683614
• Product Code: HBE
• UDI-Device Identifier: 00845384012627
• UDI-Public: 00845384012627
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K113476
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/19/2021

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 Model Number: S-1R-G1
• Device Catalogue Number: S-1R-G1
• Device Lot Number: P303143675
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/26/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/31/2021
• Initial Report FDA Received Date: 06/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1