MAUDE Adverse Event Report: DEPUY FRANCE S.A.S.-SAINT PRIEST ¿ REG# 3003895575 METAGLENE HOLDER; FRENCH EXTREMITY INSTS.(ONII)

Catalog Number 230787005

Device Problem Device Damaged Prior to Use (2284)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/09/2017

Event Type  malfunction  

Manufacturer Narrative

This complaint is under investigation.Depuy will notify the fda of the results of the investigation once it has been completed.(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

The tip was damaged when the customer received the kit.

Manufacturer Narrative

Examination of the returned instruments confirmed the reported event of the tips being damaged.The overall condition of the instruments indicates heavy usage.Tightening the internal rod before fully inserting the hex head tip in the holes may widen the slots of the holder, creating an oversized condition and damaging the internal rod.The root cause is attributed to device wear from normal use and servicing.Based on the root cause determination of device wear from normal use and servicing, the need for corrective action is not indicated.Continue to monitor per sep-(b)(4).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.

• Brand Name: METAGLENE HOLDER
• Type of Device: FRENCH EXTREMITY INSTS.(ONII)
• Manufacturer (Section D): DEPUY FRANCE S.A.S.-SAINT PRIEST ¿ REG# 3003895575; 7 allée irène joliot curie; bp 256; saint priest cedex, rhone-alpes 69801 ; FR 69801
• Manufacturer (Section G): DEPUY FRANCE S.A.S.-SAINT PRIEST ¿ REG# 3003895575; 7 allée irène joliot curie; bp 256; saint priest cedex, rhone-alpes 69801 ; FR 69801
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743725905
• MDR Report Key: 6292188
• MDR Text Key: 66219504
• Report Number: 1818910-2017-11713
• Device Sequence Number: 1
• Product Code: HWA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062250
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 02/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 230787005
• Device Lot Number: 5269145
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/28/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/27/2016
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1