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

Model Number	N/A
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional 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 or Problem Description
No further event information available at the time of this report.

• Brand Name: COMP REV GLEN BSPLT REAMER
• Common Device Name: REAMER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9416246
• Report Number: 0001825034-2019-05457
• Device Sequence Number: 2423953
• Product Code: HTO
• UDI-Device Identifier: 00880304471191
• UDI-Public: 00880304471191
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: EXEMPT
• 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): 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
• Operator of Device: 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 Received by Manufacturer: 12/04/2019
• Supplement Date Received by Manufacturer: 03/16/2020
• Initial Report FDA Received Date: 12/05/2019
• Supplement Report FDA Received Date: 03/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other