MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 CORAIL AMT NECK SEG 135D SHORT; HIP INSTRUMENTS : FEMORAL TRIALS

Catalog Number L94007

Device Problem Device Reprocessing Problem (1091)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/01/2018

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

We examined our loan sets (6) and found many had this debris, product codes l94003, l94004, l94005, l94006, l94007 (1 set), six sets.We examined our loan sets (6) and found many had this debris, these have all been cleaned and remain in circulation.They are now inspected when they return to our facility, and none have been found to have further debris build up.

Manufacturer Narrative

(b)(4).The affected devices were not returned for analysis.The information provided was evaluated.A field safety action was initiated to address this issue.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.The issue will be monitored through post market surveillance reviews.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.

• Brand Name: CORAIL AMT NECK SEG 135D SHORT
• Type of Device: HIP INSTRUMENTS : FEMORAL TRIALS
• Manufacturer (Section D): DEPUY FRANCE SAS - 3003895575; 7 allee irene joliot-curie; b.p. 256; saint priest cedex 69801 ; FR 69801
• MDR Report Key: 7494021
• MDR Text Key: 107580387
• Report Number: 1818910-2018-59094
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 10603295325185
• UDI-Public: 10603295325185
• 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: 04/11/2018

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: L94007
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/11/2018
• Initial Date FDA Received: 05/08/2018
• Supplement Dates Manufacturer Received: 11/12/2018
• Supplement Dates FDA Received: 11/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1