MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC 1818910 GLOBAL AP HUM HEAD DISTRACTOR; EXTREMITY INSTRUMENTS : EXTRACTION INSTRUMENTS

Catalog Number	213001120
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	04/04/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
Procedure was hemi shoulder arthroplasty converting to a total reverse shoulder.Instruments being used was being placed under the collar implant and the tip broke off the instrument and the piece was retrieved from shoulder.A like instrument was being used and one of the tines of the instrument became bent.At this point the collar was successfully removed from the humeral implant.Patient consequence? :no.Patient consequence description: broke from instrument was found and removed from table.Action taken for procedure: like instrument was used but it bent the instrument but at that point the surgeon had achieved removal of the implant.Is the information being submitted for this complaint all the details that are known/available regarding this event? : yes.
Additional Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Product complaint #: (b)(4).Investigation summary: examination of the returned device confirmed the reported event.Depuy synthes considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.

• Brand Name: GLOBAL AP HUM HEAD DISTRACTOR
• Common Device Name: EXTREMITY INSTRUMENTS : EXTRACTION INSTRUMENTS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7476281
• Report Number: 1818910-2018-58659
• Device Sequence Number: 11033824
• Product Code: LXH
• UDI-Device Identifier: 10603295090656
• UDI-Public: 10603295090656
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/05/2018

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
• Operator of Device: Health Professional
• Device Catalogue Number: 213001120
• Device Lot Number: AF0212
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2018
• Initial Date Received by Manufacturer: 04/05/2018
• Supplement Date Received by Manufacturer: 05/21/2018; 08/02/2018
• Initial Report FDA Received Date: 05/01/2018
• Supplement Report FDA Received Date: 05/25/2018; 08/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1