MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 ANGLED ACET INSERTR; HIP INSTRUMENTS : INSERTION DEVICES

Model Number 9200-10-029

Device Problems Use of Device Problem (1670); Component Missing (2306)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/01/2019

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 the sales rep was in sterile processing looking for instruments and found the inserter on a table with the bottom cap missing and the black handle off.We did get the black handle but not the silver end cap.Do not know when this happened.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the 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.H10 additional narrative: product complaint # (b)(4).Investigation summary: the device was reviewed by the supplier and the following statement was received: it appears to have been modified from its original manufacture root cause unjustified.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: ANGLED ACET INSERTR
• Type of Device: HIP INSTRUMENTS : INSERTION DEVICES
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• MDR Report Key: 8930198
• MDR Text Key: 155555958
• Report Number: 1818910-2019-102155
• Device Sequence Number: 1
• Product Code: HWR
• UDI-Device Identifier: 10603295221890
• UDI-Public: 10603295221890
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 08/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9200-10-029
• Device Catalogue Number: 920010029
• Device Lot Number: PC34716001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2019
• Date Manufacturer Received: 04/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1