MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 GLO FX/ADV INSERTER/EXTRACTOR

Catalog Number	212801020
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	11/27/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).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
During use to extract the humeral component, the thread of the slap hammer from the extraction instruments snapped off inside the tool.We were not able to remove it.Sixty minute delay to procedure.No ae to patient.
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
Investigation summary: evaluation of the returned device confirms 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: GLO FX/ADV INSERTER/EXTRACTOR
• Common Device Name: INSERTER/EXTRACTOR
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910 ; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7125159
• Report Number: 1818910-2017-51876
• Device Sequence Number: 1629682
• Product Code: LXH
• UDI-Device Identifier: 10603295088028
• UDI-Public: 10603295088028
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 11/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 212801020
• Device Lot Number: AH0900
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 04/02/2018
• Initial Date Received by Manufacturer: 11/26/2017
• Supplement Date Received by Manufacturer: 09/12/2018; 11/05/2018
• Initial Report FDA Received Date: 12/18/2017
• Supplement Report FDA Received Date: 09/19/2018; 11/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR