MAUDE Adverse Event Report: ZIMMER BIOMET, INC. HYBRID GLENOID IMPACTOR; INSTRUMENT, EXTREMITIES

Catalog Number	406156
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
It was reported that fractured instrument was found in a tray by distributor office personnel.Unable to tie back to specific case or patient.
Event or Problem Description
Upon receiving additional information of the reported event, it was determined to be not reportable.The initial report was submitted in error and should be voided.
Additional Manufacturer Narrative
The following sections were updated/corrected: b4; b5; d4; d11; g4; g7; h1; h2; h3.Upon receiving additional information of the reported event, it was determined to be not reportable.The initial report was submitted in error and should be voided.

• Brand Name: HYBRID GLENOID IMPACTOR
• Common Device Name: INSTRUMENT, EXTREMITIES
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9633356
• Report Number: 0001825034-2020-00403
• Device Sequence Number: 502027
• Product Code: HWA
• UDI-Device Identifier: 00880304456440
• UDI-Public: (01)00880304456440
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2020

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: 406156
• Device Lot Number: 021260
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/08/2020
• Supplement Date Received by Manufacturer: 03/25/2020
• Initial Report FDA Received Date: 01/27/2020
• Supplement Report FDA Received Date: 03/26/2020
• 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: NI
• Patient Sequence Number: 1