MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 HASTINGS CORK SCREW/HEAD EXT.; HIP INSTRUMENTS : SCREWDRIVERS

Catalog Number 963253000

Device Problems Defective Device (2588); Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/01/2020

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

Hospital called to report that surgeons using the single piece cork screw t-handle (femoral head extraction tool) during hemi-arthroplasty and thr cases are not happy with the way the instrument is performing, nurse reported that surgeons complain the design is not suitable causing the cork screw to pull out of the bone too easily (i.E.Will not get good enough purchase).They are using a hospital owned t handled corckscrew with a thicker shaft and end as a back up / replacement for surgeons that do not wish to use the one in the depuy kits.The hospital would like to look into depuy alternatives and replace out.

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: no device was received.Root cause undetermined.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: HASTINGS CORK SCREW/HEAD EXT.
• Type of Device: HIP INSTRUMENTS : SCREWDRIVERS
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• MDR Report Key: 9995382
• MDR Text Key: 191146724
• Report Number: 1818910-2020-11249
• Device Sequence Number: 1
• Product Code: HWB
• 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
• Report Date: 04/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 963253000
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1