MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC 8.0 CM MEDIUM ATTACHMENT; DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC)

Catalog Number	MEDIUM
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2023
Type of Reportable Event	Malfunction
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.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: the actual device was returned for evaluation.During repair, an evaluation was performed and it was determined that the device had fell apart - unattached therefore, the reported condition that the device was not working properly was confirmed.The assignable root cause of this condition was determined to be traced to component failure due to wear.Udi - (b)(4).
Event or Problem Description
It was reported from switzerland that during service and evaluation, it was determined that the ball bearings of the attachment device fell apart, internal parts of the ball bearings were missing, the cutter device could not be inserted, the nose tube was bent/damaged, there was bearing damage, missing components, the cutter could not be locked/secured, and the device fell apart - unattached.It was further determined that the device failed pretest for lock operation verification and cutter insertion verification.It was noted in the service order that the device was not working properly.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 not reported, however, it was reported that the event occurred in 2023.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.

• Brand Name: 8.0 CM MEDIUM ATTACHMENT
• Common Device Name: DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC)
• Manufacturer (Section D): DEPUY SYNTHES PRODUCTS LLC; 4500 riverside drive; palm beach gardens FL 33410
• Manufacturer Contact: kate karberg ; 4500 riverside drive; palm beach gardens, FL ; 3035526892
• MDR Report Key: 17737564
• Report Number: 1045834-2023-01337
• Device Sequence Number: 6615236
• Product Code: ERL
• UDI-Device Identifier: 00845384004899
• UDI-Public: 00845384004899
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K011444
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial

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 Catalogue Number: MEDIUM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/11/2023
• Initial Report FDA Received Date: 09/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/17/2015
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown