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

Catalog Number 230793000

Device Problem Device Issue (2379)

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

Event Date 03/09/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

During procedure, whilst using above screwdriver to lock the screw joining the delta epiphyseal body to the delta ha stem, the tip of the screwdriver became burred, spinning inside the hex-head of the locking screw.The surgeon believed the locking screw had completely seated home - locking the proximal part to the distal stem but commented on the fact that the screwdriver tip was now burred.Surgeon was able to complete the screw locking function.Defective instrument tagged, warehouse notified to send in replacement.No ae to patient.Patient outcome post surgery: stable shoulder joint.One minute delay in surgery.

Manufacturer Narrative

Investigation summary: the device associated with the reported event was not returned for evaluation.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, will be filed as appropriate.

• Brand Name: 3.5 CANNULATED SCREWDRIVER
• Type of Device: SCREWDRIVERS
• Manufacturer (Section D): DEPUY FRANCE SAS 3003895575; 7 allée irène joliot curie; bp 256; saint priest cedex 69801 ; FR 69801
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910 ; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46582-0988 ; 5743725905
• MDR Report Key: 7398825
• MDR Text Key: 104422644
• Report Number: 1818910-2018-56706
• Device Sequence Number: 1
• Product Code: HXX
• UDI-Device Identifier: 10603295116585
• UDI-Public: 10603295116585
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 03/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 230793000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/18/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 91 YR