MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 DXTEND SCREW LOCK D4.5X30MM; DELTA XTEND IMPLANTS : SCREWS

Model Number 130790030

Device Problem Difficult to Advance (2920)

Patient Problem No Code Available (3191)

Event Date 03/16/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

(b)(6) drilled and measured hole for metaglene screw as per surgical technique.He was unable to screw the screw in so it was protruding outwards.He red rolled and remeasured but still unable to screw in the screw so it was flush to the metaglene.In the end he opened another screw size 30 and was able to screw it straight in.Original screw was faulty.No adverse injury to patient.Procedure delayed by a few minutes to redrill and retry to instill.The screw in question has been sent for sterilization and can then be collected for investigation from theaters at the hospital.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy as not synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: product complaint (b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide complaint database search found no other reported incident(s) against the provided product/lot combination(s) since release for distribution.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Corrective action was not indicated.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: DXTEND SCREW LOCK D4.5X30MM
• Type of Device: DELTA XTEND IMPLANTS : SCREWS
• Manufacturer (Section D): DEPUY FRANCE SAS - 3003895575; 7 allee irene joliot-curie; b.p. 256; saint priest cedex 69801 ; FR 69801
• MDR Report Key: 9911821
• MDR Text Key: 190339907
• Report Number: 1818910-2020-09925
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 10603295027843
• UDI-Public: 10603295027843
• Combination Product (y/n): N
• PMA/PMN Number: K062250
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 03/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 130790030
• Device Catalogue Number: 130790030
• Device Lot Number: 5328058
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1