MAUDE Adverse Event Report: ZIMMER BIOMET, INC. AUGMENT REAMER DRIVER; INSTRUMENT SHOULDER

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/23/2021
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.
Event or Problem Description
It was reported, when reaming the glenoid to prepare for augmented glenoid, the reamer was catching on some of the retractors causing the hex ball reamer shaft to break.No adverse events have been reported as a result of the malfunction.Attempts have been made and there is no further information at this time.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
(b)(4) reported event was confirmed as visual examination of the returned product identified the ball hex feature is fractured.Device was sent for further testing and found the fracture surface artifacts indicate a ductile torsional overload fracture.Device history record was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause could not be determined.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
Upon reassessment, it has been determined that this device did not cause or contribute to serious injury and has not been reported for doing so previously.The initial report was forwarded in error and should be voided.
Additional Manufacturer Narrative
(b)(4).Upon reassessment, it has been determined that this device did not cause or contribute to serious injury and has not been reported for doing so previously.The initial report was forwarded in error and should be voided.

• Brand Name: AUGMENT REAMER DRIVER
• Common Device Name: INSTRUMENT SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11821097
• Report Number: 0001822565-2021-01341
• Device Sequence Number: 3224310
• Product Code: KWS
• UDI-Device Identifier: 00889024575202
• UDI-Public: (01)00889024575202(10)64878851
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: K193180
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/20/2021

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: SBGL3701
• Device Lot Number: 64878851
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/23/2021
• Supplement Date Received by Manufacturer: 06/22/2021; 10/19/2021
• Initial Report FDA Received Date: 05/13/2021
• Supplement Report FDA Received Date: 07/01/2021; 10/21/2021
• 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
• Patient Weight: 100