MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. DXTEND SCREW LOCK D4.5X42MM; SHOULDER OTHER IMPLANT

Catalog Number 130790042

Device Problem Disassembly (1168)

Patient Problem No Information (3190)

Event Date 07/05/2016

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

During total shoulder replacement, an inner screw was not tightened enough and came off from an outer screw when the surgeon inserted a screwdriver tip in the screw.By using a replacement, the surgery was completed with a 20-minute delay.There was no harm to the patient.

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

The complaint description states that during total shoulder replacement, an inner screw was not tightened enough and came off from an outer screw when the surgeon inserted a screwdriver tip in the screw.The device associated to the complaint was not returned for analysis.The dhr analysis performed did not reveal any anomalies that could be related to the issue reported on the complaint.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.Depuy still 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: DXTEND SCREW LOCK D4.5X42MM
• Type of Device: SHOULDER OTHER IMPLANT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC.; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC.; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743725905
• MDR Report Key: 5781723
• MDR Text Key: 49134599
• Report Number: 1818910-2016-22860
• Device Sequence Number: 1
• Product Code: HSD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K081620
• 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: 07/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2020
• Device Catalogue Number: 130790042
• Device Lot Number: 5253915
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/12/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/29/2015
• 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