MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. SCREW DEPTH GAUGE; SHOULDER INSTRUMENT/TRIAL

Catalog Number 230791001

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 10/25/2016

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.(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

Plastic is broke on the gauge.

Manufacturer Narrative

Examination of the returned device found a crack in the plastic casing at the top of the scale.A complaint database search finds no additional reports against the complaint sample product and lot combination.A two-year complaint database search against product code 230791001 did not reveal any trends of broken depth gauge plastic casing.The root cause is attributed to suspected misuse.In addition, the device has been subjected to heavy usage.Based on the root cause determination of suspected misuse and no trends of depth gauge breakage, the need for corrective action is not indicated.Monitor through sep-419.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: SCREW DEPTH GAUGE
• 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: 6124053
• MDR Text Key: 60755927
• Report Number: 1818910-2016-32081
• Device Sequence Number: 1
• Product Code: HTJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 10/25/2016

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: 230791001
• Device Lot Number: 5001931
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/25/2016
• Initial Date FDA Received: 11/23/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/19/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/10/2009
• 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