MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP RVS 3.2MM DRL; INSTRUMENT, SHOULDER

Model Number N/A

Device Problem Separation Failure (2547)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/26/2019

Event Type  malfunction  

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.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2019 - 01580.

Event Description

It was reported that the patient underwent a shoulder procedure.While the surgeon was attempting to drill the hole the drill bit seized up inside the vrs drill guide.No adverse events have been reported as a result of the malfunction.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional and/or corrected information.Reported event was confirmed by review of the product returned.Visual inspection showed that the drill seized in the vrs inserter.As the drill was seized no dimensional analysis was performed on the vrs inserter.Dimensions taken on the drill are found to be confirming.Dhr was reviewed and no discrepancies were found.Root cause was unable to 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.

• Brand Name: COMP RVS 3.2MM DRL
• Type of Device: INSTRUMENT, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8486759
• MDR Text Key: 141037701
• Report Number: 0001825034-2019-01576
• Device Sequence Number: 1
• Product Code: HTW
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 04/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2019
• 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: 405883
• Device Lot Number: 028680
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: (B)(4), COMPR VRS INSERTER, (B)(4); (B)(4), COMPR VRS INSERTER, 814100