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

Model Number N/A

Device Problem Fracture (1260)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/10/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).(udi): n/a.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2020-04267.

Event Description

It was reported that the instrument broke while reaming.

Event Description

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

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.

Manufacturer Narrative

(b)(4).Reported event was confirmed as visual examination of the returned product identified both items are fractured near the hex ball end.Further analysis determined 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 Description

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

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.

Event 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.

• Brand Name: AUGMENT REAMER DRIVER
• Type of Device: INSTRUMENT SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11123050
• MDR Text Key: 225297236
• Report Number: 0001822565-2020-04266
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• PMA/PMN Number: K193180
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: SBGL3701
• Device Lot Number: 64832653
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1