MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. HUMERAL IMPLANT DRIVER; SHOULDER INSTRUMENT/TRIAL

Catalog Number 230783000

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 12/15/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).This complaint is under investigation.Depuy will notify the fda of the results of the investigation once it has been completed.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Implant locking plate has snapped off.This case has been reported by the loan kit technician during loan kit inspection.

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

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 the implant locking plate has snapped off.The device associated to the complaint was returned for analysis.The visual analysis shows the break of the 4 screws of the lower plate.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.Previous complaints were received for a similar incident ((b)(4) and (b)(4)).The analysis performed by r&d concluded that there is a contradiction between the drawing for the screw ((b)(4)) and (b)(4) (a standard for socket countersunk screws), regarding the hexagon depth.This contradiction, allows much less material in the cross section of the screw where the fracture occurs.The 0.4mm deviation in depth between the specifications decrease the wall thickness by 25%.Furthermore, the risk management ((b)(4)) was reviewed and it did not include the failure mode identified in this complaint.The complaints were reviewed by a medical safety officer and it was concluded that there was no patient harm associated with the failure mode and the occurrence was remote.Given the low level of severity and occurrence of the failure mode no immediate actions were required and all product could be dispositioned ¿use as is¿.Based on the information received and the investigation performed, the root cause of the incident is related to product design.The discrepancy on the drawing between the standard quoted and dimensions stated will be amended and this failure mode will be included in the product risk management.These changes will be implemented through a change order.A change assessment has been created for these changes ((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: HUMERAL IMPLANT DRIVER
• Type of Device: SHOULDER INSTRUMENT/TRIAL
• 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: 6245351
• MDR Text Key: 65056232
• Report Number: 1818910-2017-10733
• Device Sequence Number: 1
• Product Code: HWR
• Combination Product (y/n): N
• Reporter Country Code: US
• 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,Followup
• Report Date: 02/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 230783000
• Device Lot Number: 5083582
• 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: 03/14/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/08/2011
• 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