MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ACTIS STRAIGHT INSERTER SHAFT; INSERTION DEVICES

Model Number 2010-07-110

Device Problems Difficult to Remove (1528); Device-Device Incompatibility (2919); Physical Resistance/Sticking (4012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/25/2020

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

It was reported that on (b)(6) 2020, the handle and the shaft did not disconnect after bha surgery.The surgeon struck around the connecting part of them by a hammer, and they disconnected.The surgery completed without surgical delay.No further information is available.

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 : examination of the returned instrument confirmed the complaint.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.Device history lot : null.Device history batch : null.Device history review : null.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

Product complaint (b)(4).Investigation summary : examination of the returned instrument confirmed the complaint.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.Functional testing with both instrument confirmed the complaint.The pair properly mate, but the inserter is difficult to remove from handle.The root cause is attributed to design, a dimensional change conducted through eco-265670 caused an interference fit at adverse conditions between the shafts and handle geometry that was implemented in (b)(6) 2008.Commercialized product development determined no design solutions identified which would reduce the risk without introducing new risks, no corrective action pursued at this time.Complaints will be monitored under post market surveillance sep 419.

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

• Brand Name: ACTIS STRAIGHT INSERTER SHAFT
• Type of Device: INSERTION DEVICES
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 9801716
• MDR Text Key: 184547024
• Report Number: 1818910-2020-07133
• Device Sequence Number: 1
• Product Code: KWL
• UDI-Device Identifier: 10603295393993
• UDI-Public: 10603295393993
• Combination Product (y/n): N
• PMA/PMN Number: K150862
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/24/2020

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: 2010-07-110
• Device Catalogue Number: 201007110
• Device Lot Number: SO2043260
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2020
• Initial Date Manufacturer Received: 02/24/2020
• Initial Date FDA Received: 03/06/2020
• Supplement Dates Manufacturer Received: 03/10/2020; 03/23/2020; 05/10/2020
• Supplement Dates FDA Received: 03/12/2020; 03/26/2020; 05/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1