MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 3.5 CANNULATED SCREWDRIVER; EXTREMITY INSTRUMENTS : SCREWDRIVERS

Model Number 2307-93-000

Device Problems Material Twisted/Bent (2981); Naturally Worn (2988); Illegible Information (4050)

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

Event Date 06/23/2021

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 the case, the surgeon advised that the head of the screwdriver was rounded and therefore making it difficult engage the head of a screw.Average wear and tear, item needs to be replaced.No adverse effects on the surgery.Not able to read on instruments as all text/writing has worn off - including the depuy logo.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary - examination of the returned device confirmed the reported event.The noted wear is consistent with device use from normal use and servicing and the investigation did not establish a need for corrective action.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 - lot information not available corrected: h3.

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.Material twisted/bent was updated to naturally worn.

• Brand Name: 3.5 CANNULATED SCREWDRIVER
• 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: 12151081
• MDR Text Key: 261009122
• Report Number: 1818910-2021-14955
• Device Sequence Number: 1
• Product Code: HXX
• UDI-Device Identifier: 10603295116585
• UDI-Public: 10603295116585
• Combination Product (y/n): N
• 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: 06/21/2021

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: 2307-93-000
• Device Catalogue Number: 230793000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2021
• Initial Date Manufacturer Received: 06/21/2021
• Initial Date FDA Received: 07/12/2021
• Supplement Dates Manufacturer Received: 08/02/2021; 09/10/2021
• Supplement Dates FDA Received: 08/11/2021; 09/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1