MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP REV GLEN BSPLT REAMER

Model Number N/A

Device Problem Off-Label Use (1494)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Multiple mdr's were filed in association with this reporting: 0001825034 - 2019 - 05468.Report source: (b)(6).The investigation is in process.Once the investigation has been completed, a follow-up/final report will be submitted.The physician still uses the device.

Event Description

It was reported the surgeon has inadvertently chipped off chunks of the patient glenoid while reaming due to the inability to clearly visualize the glenoid.The surgeon admittedly uses the reamer off-label.No further information is available at the time of this reporting.

Manufacturer Narrative

No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Medical records were not provided.Dhr was reviewed and no discrepancies relevant to the reported event were found.As per the complaint info, it was identified the root cause of the reported issue is attributed to user error due to incorrect usage of the device.If any further information which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

No further event information available at the time of this report.

• Brand Name: COMP REV GLEN BSPLT REAMER
• Type of Device: REAMER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9416246
• MDR Text Key: 169238798
• Report Number: 0001825034-2019-05457
• Device Sequence Number: 1
• Product Code: HTO
• UDI-Device Identifier: 00880304471191
• UDI-Public: 00880304471191
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/18/2020

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
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 405806
• Device Lot Number: 405807
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/04/2019
• Initial Date FDA Received: 12/05/2019
• Supplement Dates Manufacturer Received: 03/16/2020
• Supplement Dates FDA Received: 03/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other