MAUDE Adverse Event Report: DEPUY FRANCE SAS¿ 3003895575 DXTEND SCREW LOCK D4.5X30MM; SHOULDER OTHER IMPLANT

Catalog Number 130790030

Device Problems Detachment Of Device Component (1104); Fracture (1260); Defective Component (2292)

Patient Problem No Information (3190)

Event Date 10/02/2017

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

During fixation of delta xtend metaglen (1307-60-000) with a locking screw 4.5 mm (1307-90-030, lot 5269983) the small locking screw in the screw head fell out.Customer could take out the small screw with a forceps and removed the locking screw 4.5 mm.Customer took a new locking screw 4.5 mm.Customer does not require an investigation!.

Event Description

On (b)(6) 2017 update der reviewed and discussed with product analyst.After pulling drawings, it was determined that a manufacturing issue may have been the most likely cause of the incident.The small set screw, that provides head expansion of the 4.5mm locking screw after it is set, should not just fall out of the head of the 4.5mm screw, as it appears to have done, according to the der.Therefore, a follow-up medwatch will be sent to address this, and "manufacturing problem suspected: other" added to product harm.

Manufacturer Narrative

The complaint description states during fixation of delta xtend metaglen (1307-60-000) with a locking screw 4.5 mm (1307-90-030, lot 5269983) the small locking screw in the screw head fell out.No device associated with this report was received for examination.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.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 LOCK D4.5X30MM
• Type of Device: SHOULDER OTHER IMPLANT
• Manufacturer (Section D): DEPUY FRANCE SAS¿ 3003895575; 7 allée irène joliot curie; bp 256; saint priest cedex 69801 ; FR 69801
• Manufacturer (Section G): DEPUY FRANCE SAS¿ 3003895575; 7 allée irène joliot curie; bp 256; saint priest cedex 69801 ; FR 69801
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743725905
• MDR Report Key: 6928210
• MDR Text Key: 89588961
• Report Number: 1818910-2017-26198
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 10603295027843
• UDI-Public: 10603295027843
• 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,Followup
• Report Date: 10/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 130790030
• Device Lot Number: 5269983
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/10/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2016
• 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