MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 LOCKING SCREWDRIVER BODY; EXTREMITY INSTRUMENTS : SCREWDRIVERS

Model Number 2307-92-003

Device Problems Break (1069); Illegible Information (4050)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/30/2021

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

It was reported that the tynes broke off delta locking driver.

Manufacturer Narrative

Product complaint #: (b)(4).Investigation summary: examination of the returned device identified breakage.Root cause and corrective action are documented in the capa system.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Device history lot: the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).Where the product and lot code was provided, a manufacturing records evaluation (mre) was not performed.Corrected: h3, h6 (medical device problem code) h6 medical device problem code: code for illegible etch is now being retracted.

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: LOCKING SCREWDRIVER BODY
• Type of Device: EXTREMITY INSTRUMENTS : SCREWDRIVERS
• Manufacturer (Section D): DEPUY FRANCE SAS - 3003895575; 7 allee irene joliot-curie; b.p. 256; saint priest cedex 69801 ; FR 69801
• MDR Report Key: 11633791
• MDR Text Key: 244404289
• Report Number: 1818910-2021-07432
• Device Sequence Number: 1
• Product Code: HXX
• UDI-Device Identifier: 10603295116561
• UDI-Public: 10603295116561
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 03/30/2021

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: 2307-92-003
• Device Catalogue Number: 230792003
• Device Lot Number: 5294425
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2021
• Initial Date Manufacturer Received: 03/30/2021
• Initial Date FDA Received: 04/08/2021
• Supplement Dates Manufacturer Received: 05/10/2021; 05/26/2021
• Supplement Dates FDA Received: 05/25/2021; 05/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 57 YR