MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC MINIMAL ACCESS ATTACHMENT; DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)

Model Number MA-D20

Device Problems Break (1069); Detachment of Device or Device Component (2907); Mechanical Jam (2983); Excessive Heating (4030)

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

Event Type  malfunction  

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.Additional narrative: as of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.Udi: (b)(4).

Event Description

It was reported that the minimal access attachment device bearings were going out and it felt rough when it was rotating causing it to overheat.It was not reported if the device was used in surgery, or if there was patient involvement.It was not reported if there were any delays in a surgical procedure or if a spare device was available for use.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 report will be submitted accordingly.

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: b5: upon subsequent follow-up with the customer, additional information was received.The reporter clarified that the roughness of the bearings could be felt when the device was rotated.It was further reported that they were not separating but there was a grinding feel when the device was being used.H6: correction: upon further review of the complaint investigation, it was determined that the device code of detachment of device or device component was not applicable and this device code has been removed.The device code of break has been added.

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: device evaluation: the actual device was returned for evaluation.During repair, it was determined that the reported condition that the device bearings felt rough when it was rotating causing it to overheat was not confirmed.Therefore, an assignable root cause for the reported conditions of heat, moving parts did not move smoothly and bearing damage were not determined.However, during evaluation, it was determined that the device could not engage the attachment.It was further determined that the device failed pretest for lock assessment: (cutter / sleeve are properly secured).The assignable root cause was determined to be due to component failure from wear.

• Brand Name: MINIMAL ACCESS ATTACHMENT
• Type of Device: DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)
• 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: 16060236
• MDR Text Key: 307000312
• Report Number: 1045834-2022-01768
• Device Sequence Number: 1
• Product Code: HBE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K042783
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/28/2022

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 Model Number: MA-D20
• Device Catalogue Number: MA-D20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/23/2022
• Initial Date FDA Received: 12/28/2022
• Supplement Dates Manufacturer Received: 12/29/2022; 02/06/2023
• Supplement Dates FDA Received: 01/06/2023; 02/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/23/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1