MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 G C.A.P. SIZER/DRILL GD HANDLE; SHOULDER INSTRUMENT/TRIAL

Catalog Number 223080060

Device Problem Connection Problem (2900)

Patient Problem No Information (3190)

Event Date 06/19/2017

Event Type  malfunction  

Manufacturer Narrative

This complaint is still under investigation.Depuy will notify the fda of the results of this 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

It was reported that the drill guide handle would not firmly stay attached to the drill guides.Not sure if the handle is defective or if it never actually firmly holds the drill guides properly.

Manufacturer Narrative

Visual analysis of the submitted device revealed the dowel pin, lee spring, plunger, and plug components required to attach the drill guides are missing.Depuy considers the investigation closed.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: G C.A.P. SIZER/DRILL GD HANDLE
• Type of Device: SHOULDER INSTRUMENT/TRIAL
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743725905
• MDR Report Key: 6716781
• MDR Text Key: 80136492
• Report Number: 1818910-2017-21207
• Device Sequence Number: 1
• Product Code: HWT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 06/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 223080060
• Device Lot Number: A0311
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/19/2017
• Initial Date FDA Received: 07/17/2017
• Supplement Dates Manufacturer Received: 08/15/2017
• Supplement Dates FDA Received: 08/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Age: 56 YR