MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US GLOBAL ORIGINAL BROACH HANDLE; HANDLES

Catalog Number	223502000
Medical Device Problem Codes	Device-Device Incompatibility (2919); Naturally Worn (2988)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/12/2018
Type of Reportable Event	Malfunction
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
Instrument issue during: revision (l) hemi arthroplasty to reverse.Internal thread at the top of the instrument, that the slap hammer attaches to, is damaged beyond repair.We are unable to connect the slap hammer at all.The side screw is also threaded & we required locking pliers to turn it so we could lock the handle onto the stem.Action taken to manage issue: alternative hospital instruments used to extract the humeral stem.No delay to procedure.No ae to patient.
Additional Manufacturer Narrative
Product complaint # pc-(b)(4).Investigation summary no device was received for examination, therefore the reported event could not be confirmed.Depuy considers the investigation closed.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 ORIGINAL BROACH HANDLE
• Common Device Name: HANDLES
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7762383
• Report Number: 1818910-2018-66094
• Device Sequence Number: 1860737
• Product Code: HTQ
• UDI-Device Identifier: 10603295105367
• UDI-Public: 10603295105367
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: NI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/12/2018

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: 223502000
• Device Lot Number: AG1095E
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/12/2018
• Supplement Date Received by Manufacturer: 11/15/2018
• Initial Report FDA Received Date: 08/08/2018
• Supplement Report FDA Received Date: 11/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 72 YR