MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US GLO ADV GLENOID REAMER 44MM; EXTREMITY INSTRUMENTS : REAMERS

Catalog Number	212861001
Medical Device Problem Code	Dull, Blunt (2407)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	09/13/2019
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
It was reported that this was an entire artificial joint replacement procedure treating shoulder joint osteoarthropathy on (b)(6) 2019.The surgeon used the reamer (212861001) for scraping the scapula.It took time for the scraping because the reamer was not sharp enough.The procedure was delayed less than 30 minutes.There was no harm to the patient.The device was the first use when the issue occurred.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Product complaint # (b)(4).The device was reviewed and confirmed the device is worn.Root cause attributed to the device being worn from normal use and servicing.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Added: d4(lot number), h4.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: GLO ADV GLENOID REAMER 44MM
• Common Device Name: EXTREMITY INSTRUMENTS : REAMERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9156522
• Report Number: 1818910-2019-107809
• Device Sequence Number: 2138968
• Product Code: HTO
• UDI-Device Identifier: 10603295089230
• UDI-Public: 10603295089230
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/13/2019

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: 212861001
• Device Lot Number: AF0511
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2019
• Initial Date Received by Manufacturer: 09/13/2019
• Supplement Date Received by Manufacturer: 10/04/2019; 11/18/2019
• Initial Report FDA Received Date: 10/04/2019
• Supplement Report FDA Received Date: 10/21/2019; 11/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1