MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US GLOBAL AP BALL CYLIN TRL ASSEM; EXTREMITY INSTRUMENTS : HUMERAL TRIALS

Catalog Number 213000000

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/01/2017

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (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

Surgeon adjusting trial cylinder during fitting and the spring separated from the device.He also noted that it initially was not snapping into the trial stem as per usual.Minimal delay did not affect surgery as another device was available.No issues with the new trial assembly.Patient consequence? :no.Is the information being submitted for this complaint all the details that are known/available regarding this event? : yes.

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Product complaint #: (b)(4).Investigation summary: examination of the returned device confirmed the reported event.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: GLOBAL AP BALL CYLIN TRL ASSEM
• Type of Device: EXTREMITY INSTRUMENTS : HUMERAL TRIALS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46581-0988 ; 5743725905
• MDR Report Key: 7150538
• MDR Text Key: 95931296
• Report Number: 1818910-2017-52579
• Device Sequence Number: 1
• Product Code: HWT
• UDI-Device Identifier: 10603295090366
• UDI-Public: 10603295090366
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 11/29/2017

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: 213000000
• Device Lot Number: HG4666
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/29/2017
• Initial Date FDA Received: 12/28/2017
• Supplement Dates Manufacturer Received: 01/30/2018; 08/02/2018
• Supplement Dates FDA Received: 01/31/2018; 08/03/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/18/2017
• 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