MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 METAGLENE GUIDE PIN DIA 2.5MM; EXTREMITY INSTRUMENTS : PIN GUIDES

Catalog Number 230787004

Device Problem Bent (1059)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/12/2018

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

An orthokit technician reported that two pins were bent, the incident was detected during incoming inspection.No patient involvement.

Manufacturer Narrative

(b)(4).Investigation summary the issue reported is confirmed.Similar complaints have been reported for the affected product code.The root cause of the issue is attributed to supplier design and manufacturing process.A risk assessment was performed which concluded that based on the very low patient risk and complaint rate, the supplier could continue to manufacture with the current process.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.

Manufacturer Narrative

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

• Brand Name: METAGLENE GUIDE PIN DIA 2.5MM
• Type of Device: EXTREMITY INSTRUMENTS : PIN GUIDES
• Manufacturer (Section D): DEPUY FRANCE SAS - 3003895575; 7 allee irene joliot-curie; b.p. 256; saint priest cedex 69801 ; FR 69801
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46582 0988
• Manufacturer Contact: chad gibson ; 700 orthopaedic dr.; warsaw, IN 46582-0988 ; 5743725905
• MDR Report Key: 7399041
• MDR Text Key: 104471814
• Report Number: 1818910-2018-56749
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 10603295116455
• UDI-Public: 10603295116455
• 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,Followup
• Report Date: 03/09/2018

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: 230787004
• Device Lot Number: 5302738
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2018
• Initial Date Manufacturer Received: 03/09/2018
• Initial Date FDA Received: 04/05/2018
• Supplement Dates Manufacturer Received: 10/08/2018; 10/08/2018
• Supplement Dates FDA Received: 10/09/2018; 10/31/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/24/2017
• 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