MAUDE Adverse Event Report: ZIMMER BIOMET, INC. CANN DRIVER BIT HEX 1.5MM AO; TRAUMA, INSTRUMENT

Model Number N/A

Device Problem Misassembled (1398)

Patient Problem No Code Available (3191)

Event Date 01/16/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: unknown screw.Report source foreign-(b)(6).The 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.Product not returned.

Event Description

It was reported that during surgery, the screwdriver did not sit adequately tight in the screw.As a result, the screw could not be completely inserted.A delay of 30 minutes was reported as a result of this event.No additional patient consequences were reported.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event could not be confirmed.Inspection of the returned device revealed that the hex feature looked rounded, however, dimensional analysis of the product determined that the product, measured at the hex feature, was conforming to print specifications.Device history record was reviewed and no discrepancies were found.Root cause was unable to be determined.A summary of the investigation has been sent to the complainant.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: CANN DRIVER BIT HEX 1.5MM AO
• Type of Device: TRAUMA, INSTRUMENT
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8275056
• MDR Text Key: 134017206
• Report Number: 0001825034-2019-00323
• Device Sequence Number: 1
• Product Code: HSN
• Combination Product (y/n): N
• PMA/PMN Number: K120906
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 05/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 231201225
• Device Lot Number: 00080
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 24 YR
• Patient Weight: 70