MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMPREHENSIVE INSTRUMENTATION SHORT BASEPLATE REAMER MINI; EXTREMITIES INSTRUMENTS

Model Number	N/A
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/03/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported during a primary surgery that the glenoid reamer was dull.There was no reported patient injury as a result of the malfunction.Attempts have been made and there is no further information at this time.
Additional Manufacturer Narrative
(b)(4).H3: the customer has not indicated whether the product will be returned to zimmer biomet for investigation or not.Once this information is obtained a follow-up mdr will be submitted.H3 other text : not returned.
Additional Manufacturer Narrative
(b)(4).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
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.H6: proposed annex g code - mechanical (g04) - drill.The reported event is confirmed as the device was returned.Visual examination of the returned product identified signs of use with galling on the shaft of the reamer and nicks and gouges on the reamer itself.Medical records were not provided.A review of the device history record(s) identified no deviations or anomalies during manufacturing.A definitive root cause cannot be determined.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 is available at the time of this report.

• Brand Name: COMPREHENSIVE INSTRUMENTATION SHORT BASEPLATE REAMER MINI
• Common Device Name: EXTREMITIES INSTRUMENTS
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 18257411
• Report Number: 0001825034-2023-02857
• Device Sequence Number: 17919309
• Product Code: KWS
• UDI-Device Identifier: 00880304731523
• UDI-Public: (01)00880304731523(11)180907(10)341880
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K193373
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/06/2024

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 Model Number: N/A
• Device Catalogue Number: 110029136
• Device Lot Number: 341880
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/06/2023
• Supplement Date Received by Manufacturer: 12/05/2023; 02/28/2024
• Initial Report FDA Received Date: 12/04/2023
• Supplement Report FDA Received Date: 12/29/2023; 03/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/07/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• 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
• Patient Sex: Female