MAUDE Adverse Event Report: ZIMMER BIOMET, INC. LAG SCREW DEPTH GAUGE; GAUGE, DEPTH

Model Number N/A

Device Problem Incorrect Measurement (1383)

Patient Problem No Code Available (3191)

Event Date 02/26/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation as it was discarded at the user facility.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that during a femoral nailing procedure the lag screw was shorter than what the depth gauge had indicated was needed; the lag screw was removed and a longer one was used in its place.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.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 Description

No additional event information received.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and found to be within specification; the reported could not be confirmed.Dhr was reviewed and no discrepancies were found.No failure detected; device operated within specification.If any further information is found 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 Description

No additional information received.

• Brand Name: LAG SCREW DEPTH GAUGE
• Type of Device: GAUGE, DEPTH
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8497533
• MDR Text Key: 141431906
• Report Number: 0001825034-2019-01516
• Device Sequence Number: 1
• Product Code: HTJ
• Combination Product (y/n): N
• PMA/PMN Number: K100238
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 06/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 211201304
• Device Lot Number: FJ5EP4
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/12/2019
• Initial Date FDA Received: 04/09/2019
• Supplement Dates Manufacturer Received: 04/12/2019; 06/03/2019
• Supplement Dates FDA Received: 05/07/2019; 06/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention