MAUDE Adverse Event Report: DEPUY SPINE INC AEGIS MODULAR SCREWDRIVER

Model Number	287110550
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/29/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Device is available for evaluation.Investigation will be conducted.Follow up will be filed with the investigation results.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported that on (b)(6) 2019, prior to the anterior lumbar interbody fusion (alif) l4-l5 procedure, the modular screwdriver from the set called aegis was burred at the end, the instrument was not used as there were two on the set.This was noted before the case that the aegis did not retain to the unknown screw, it was falling off.Another screwdriver from the atb plate system of another opco was also made mention.It was not locking off and has no clear click sound when locking the screws.The procedure and patient outcome were unknown.Concomitant devices reported: unknown screw (part # unknown, lot # unknown, quantity unknown), screwdriver (part # unknown, lot # unknown, quantity 1).This complaint involves one (1) device.
Additional Manufacturer Narrative
Product complaint # (b)(4).Udi: (b)(4).
Additional Manufacturer Narrative
Product complaint # (b)(4).Udi:(b)(4).H4: additional information.

• Brand Name: AEGIS MODULAR SCREWDRIVER
• Common Device Name: SCREWDRIVER
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8705333
• Report Number: 1526439-2019-51770
• Device Sequence Number: 19400068
• Product Code: HXX
• UDI-Device Identifier: 10705034218298
• UDI-Public: (01)10705034218298
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/29/2019

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 Model Number: 287110550
• Device Catalogue Number: 287110550
• Device Lot Number: MI23727
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/29/2019
• Supplement Date Received by Manufacturer: 06/20/2019; 08/14/2019
• Initial Report FDA Received Date: 06/17/2019
• Supplement Report FDA Received Date: 07/10/2019; 08/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1