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

Catalog Number 230793000

Device Problems Break (1069); Peeled/Delaminated (1454); Material Twisted/Bent (2981); Scratched Material (3020); Physical Resistance/Sticking (4012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/22/2019

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 during implantation of the glenosphere component, the yellow delta xtend screwdriver became "cold welded" to the glenosphere implant.In order to extract the screwdriver off the glenosphere component, the glenosphere implant had to be removed from baseplate and then bought to the back table for disassembly.A new glenosphere was used in its place.No surgical delay happen.

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 has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy 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.Product complaint # (b)(4).Investigation summary: the investigation identified the device was stripped.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Date of report corrected to 01/22/2019.

• Brand Name: 3.5 CANNULATED SCREWDRIVER
• Type of Device: EXTREMITY INSTRUMENTS : SCREWDRIVERS
• Manufacturer (Section D): DEPUY FRANCE SAS 3003895575; 7 allée irène joliot curie; bp 256; saint priest cedex 69801 ; FR 69801
• MDR Report Key: 8413959
• MDR Text Key: 138579989
• Report Number: 1818910-2019-87061
• 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,health
• Type of Report: Initial,Followup,Followup
• Report Date: 01/22/2019

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 Catalogue Number: 230793000
• Device Lot Number: 5221274
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2019
• Initial Date Manufacturer Received: 02/26/2019
• Initial Date FDA Received: 03/12/2019
• Supplement Dates Manufacturer Received: 02/26/2019; 03/14/2019
• Supplement Dates FDA Received: 03/12/2019; 03/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Weight: 91