MAUDE Adverse Event Report: DEPUY FRANCE S.A.S.-SAINT PRIEST 3003895575 DXTEND SCREW NO LOCK D4.5X30MM; EXTREMITY IMPLANT

Catalog Number 130770030

Device Problem Incomplete or Missing Packaging (2312)

Patient Problem No Information (3190)

Event Date 02/16/2017

Event Type  malfunction  

Manufacturer Narrative

This complaint is still under investigation.We will notify the fda of the results of this investigation once it has depuy been completed.(b)(4).

Event Description

When the rep opened a screw box for the delta system, it was found to be empty.The box had the stickers inside, the sterile bag where the product should be was there, but the screw was not there.Another screw was used.

Manufacturer Narrative

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

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.

Manufacturer Narrative

The complaint description states that when the rep opened a screw box for the delta system, it was found to be empty.The box had the stickers inside, the sterile bag where the product should be was there, but the screw was not there.The packaging associated to the complaint was returned for analysis.The return is incomplete, the primary aluminized pouch and the screw protection sleeve are missing.The packaging items that have been returned do not exhibit any issue.To realize this packaging, its inspection, the labels application and final insertion in box, there are 4 phases handled by different operators so that any mistake at previous phase would be detected at the phase just after, in particular a pouch without screw inside.Furthermore, the quantities (product, labels) are checked at every phase and no anomaly was documented.The dhr analysis performed did not reveal any anomalies that could be related to the issue reported on the complaint.An inspection was performed on the same lot of product that was within jnj control.The screw was inside the packaging.A search into the complaints database was performed, no other similar complaint was reported for the affected product code and lot combination.Based on the information received and the investigation performed, the root cause of the incident could not be determined.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: DXTEND SCREW NO LOCK D4.5X30MM
• Type of Device: EXTREMITY IMPLANT
• Manufacturer (Section D): DEPUY FRANCE S.A.S.-SAINT PRIEST 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 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: 6411384
• MDR Text Key: 70175094
• Report Number: 1818910-2017-14822
• Device Sequence Number: 1
• Product Code: HSD
• 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: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 130770030
• Device Lot Number: 5209244
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/28/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/26/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1