MAUDE Adverse Event Report: ZIMMER BIOMET, INC. CEPHALOMEDULLARY TARGETING GUIDE STANDARD; ROD, FIXATION

Model Number N/A

Device Problem Positioning Failure (1158)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).(b)(6).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.Expected, not yet received.

Event Description

It was reported during a procedure, the surgeon implanted the nail and went to use the targeting guide to implant the distal screws.However, the screws missed the posterior holes and the drill guide did not line up as intended.Due to the event there was a ten minute delay in procedure.Further, the surgeon removed the targeting guide and free-handed inserting the screws.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Updated:corrected: lot number 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

Lot number received.

Event Description

No additional information provided.

Manufacturer Narrative

Complaint sample was evaluated and the reported event was confirmed.Visual inspection of the returned product noted general wear on the instrument indicative of use.The distal screw holes were damaged which would contribute to the misalignment, however, it is unknown when and how the guide was damaged.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 report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: CEPHALOMEDULLARY TARGETING GUIDE STANDARD
• Type of Device: ROD, FIXATION
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7992991
• MDR Text Key: 124665194
• Report Number: 0001822565-2018-05830
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• PMA/PMN Number: K091566
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 04/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2018
• 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: 00249000300
• Device Lot Number: 63180825
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1