MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC 3MM FBALL,EX,S; MOTOR, DRILL, ELECTRIC - CUTTING BURR

Model Number	S-3B-G1
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.The actual device was returned for evaluation.¿ quality engineering evaluated the device and it was determined that the reported condition was confirmed.The assignable root cause was determined to be due to improper handing, which is user error.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.Udi: (b)(4).
Event or Problem Description
It was reported from (b)(6) that during service and evaluation, it was determined that the cutter device failed visual inspection due to the burr head being cut off at the shaft with a grinding tool.It was noted that the cutting tool was destroyed.It was further determined that the cutter device was jammed into the handpiece.It was noted in the service order that the device had an unspecified malfunction.The device was returned with a motor device that did not function.This event did not occur during surgery.There was no patient involvement.There were no reports of injuries, medical intervention or prolonged hospitalization.The exact date of the event was unknown.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.

• Brand Name: 3MM FBALL,EX,S
• 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: 11672453
• Report Number: 1045834-2021-00639
• Device Sequence Number: 16993310
• Product Code: HBC
• UDI-Device Identifier: 00845384012566
• UDI-Public: 00845384012566
• 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): 03/07/2021

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 Expiration Date: 07/06/2024
• Device Model Number: S-3B-G1
• Device Catalogue Number: S-3B-G1
• Device Lot Number: N293138636
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/01/2021
• Initial Report FDA Received Date: 04/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1