MAUDE Adverse Event Report: DEPUY SPINE INC AEGIS MODULAR SCREWDRIVER

Model Number 287110550

Device Problem Material Split, Cut or Torn (4008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/29/2019

Event Type  malfunction  

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 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.

Manufacturer Narrative

Product complaint # (b)(4).Udi: (b)(4).

Manufacturer Narrative

Product complaint # (b)(4).Udi:(b)(4).H4: additional information.

• Brand Name: AEGIS MODULAR SCREWDRIVER
• Type of Device: SCREWDRIVER
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8705333
• MDR Text Key: 148264911
• Report Number: 1526439-2019-51770
• Device Sequence Number: 1
• Product Code: HXX
• UDI-Device Identifier: 10705034218298
• UDI-Public: (01)10705034218298
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: 287110550
• Device Catalogue Number: 287110550
• Device Lot Number: MI23727
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 05/29/2019
• Initial Date FDA Received: 06/17/2019
• Supplement Dates Manufacturer Received: 06/20/2019; 08/14/2019
• Supplement Dates FDA Received: 07/10/2019; 08/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1