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

Model Number 130790030

Device Problem Fracture (1260)

Patient Problems Not Applicable (3189); No Code Available (3191)

Event Date 09/22/2020

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (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

During a case at (b)(6) hospital today for a reverse shoulder (using the delta xtend prostheses) one of the heads of the locking screws snapped off making it obsolete and causing great delay to the case time itself.Eventually the surgeon had to cut the top of the head off using a small frag set as attempting a full extraction would have caused too much aggravation to the shoulder in an already complex case.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.Review of the attached photograph identified damaged screw fragments.A worldwide complaint database search found no other related reported incidents against the provided product code/lot number combination since release for distribution.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.Device history lot: a search of the depuy nonconformance (nc) quality system found no nc¿s associated with this product/lot combination.

Manufacturer Narrative

Product complaint # (b)(4).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 joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, 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.

• 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: 10643086
• MDR Text Key: 210248368
• Report Number: 1818910-2020-21708
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 10603295027843
• UDI-Public: 10603295027843
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2020
• 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: 5367488
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DXTEND SCREW LOCK D4.5X30MM; DXTEND SCREW LOCK D4.5X30 MM