MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC UNKNOWN ATTACHMENTS; MOTOR, DRILL, ELECTRIC

Catalog Number UNK-ATTACHMENTS

Device Problems Detachment of Device or Device Component (2907); Device-Device Incompatibility (2919); Separation Problem (4043)

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

Event Date 01/01/2022

Event Type  malfunction  

Event Description

It was reported from chile that the cover of an unknown crani-attachment device was missing.It was reported that a cutter device, an unknown crani-attachment device and handpiece device were stuck together.It was not reported if the event occurred during a surgical procedure.It was not reported if there was a delay to a planned procedure.It was not reported if there was a spare device available for use.There was no patient involvement reported.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 2022.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.

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: handpiece device, cutter device.The brand name is unknown udi: the part number is unknown.All attempts to obtain product information were unsuccessful.Therefore, udi is unavailable.Device manufacture date: the device manufacture date is unavailable.Reporter's phone number was not provided.The actual device has been returned and is currently pending evaluation.Once the evaluation of the device has been completed, a supplemental medwatch report will be sent 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.The actual device was returned for evaluation.Quality engineering evaluated the unknown attachment device, and it was found that the device was stuck to the associated handpiece device and cutter device.The complaint was confirmed because the cutter came in with the attachment, motor and the cutter stuck together.The repair technician was able to get the cutter off the attachment, and handpiece.The root cause of the identified failure can be traced to foreign material, blood residue, and corrosion left behind by a cleaning instrument causing the locking mechanism to malfunction - consistent with improper maintenance.The root cause for the found defect can be linked to improper maintenance.

• Brand Name: UNKNOWN ATTACHMENTS
• Type of Device: MOTOR, DRILL, ELECTRIC
• 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 33410 ; 3035526892
• MDR Report Key: 14840943
• MDR Text Key: 295261864
• Report Number: 1045834-2022-00776
• Device Sequence Number: 1
• Product Code: HBC
• Combination Product (y/n): N
• Reporter Country Code: CI
• PMA/PMN Number: K011444
• 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

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 Catalogue Number: UNK-ATTACHMENTS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2022
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/22/2022
• Initial Date FDA Received: 06/28/2022
• Supplement Dates Manufacturer Received: 03/23/2023
• Supplement Dates FDA Received: 03/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1