MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. GLOBAL AP OSTEOTOME 10MM; SHOULDER INSTRUMENT/TRIAL

Catalog Number 213001010

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/31/2016

Event Type  malfunction  

Manufacturer Narrative

Additional narrative: (b)(4).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

The alignment rod holes are damaged.The alignment rod cannot be put through the top holes.

Manufacturer Narrative

Examination of the submitted device confirmed damage to the three proximal rod holes.The damage is due to inappropriate impacts to the rod hole area.A complaint database search finds no additional reports against the complaint sample product and lot combination.A complaint database search against product code 213001010 did not reveal any trend of rod hole damage.The root cause is attributed to misuse.Based on the root cause determination of misuse and the low frequency of reported events, the need for corrective action is not indicated.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: GLOBAL AP OSTEOTOME 10MM
• 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: 6112265
• MDR Text Key: 60312028
• Report Number: 1818910-2016-31720
• Device Sequence Number: 1
• Product Code: HWM
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 10/31/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 213001010
• Device Lot Number: A0507
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/20/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/15/2007
• 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