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

Catalog Number	MA-DRIVER
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/02/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.As of this date, the device has not been returned for evaluation, therefore, the reported condition cannot be confirmed, and/or duplicated.Concomitant med products and therapy dates: bearing sleeve device; (b)(6) 2020.Initial reporters phone number: (b)(6).Udi : (b)(4).
Event or Problem Description
It was reported from (b)(6) that after an unspecified surgical procedure it was observed that components of the driver device detached from the device.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 become available, a supplemental medwatch will be submitted accordingly.
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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.H10 additional narrative: this device was returned for evaluation; however, during pre-repair assessment, it was determined that the device passed all {operational/manufactures} specifications and no failure was identified.Therefore, the reported condition was not confirmed and an assignable root cause was not determined.

• Brand Name: MINIMAL ACCESS STRAIGHT DRIVER
• 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: 10937325
• Report Number: 1045834-2020-02022
• Device Sequence Number: 641321
• Product Code: HBE
• UDI-Device Identifier: 00845384004370
• UDI-Public: 845384004370
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K042783
• 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,Followup
• Report Date (Section B): 11/18/2020

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: MA-DRIVER
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/26/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/18/2020
• Supplement Date Received by Manufacturer: 12/18/2020
• Initial Report FDA Received Date: 12/02/2020
• Supplement Report FDA Received Date: 12/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1