MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ALPS MIS DRILL GUIDE LK 2.7MM; PLATE, FIXATION

Model Number N/A

Device Problems Difficult to Remove (1528); Separation Failure (2547)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/06/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Additional concomitant medical products: 2.7x160mm calibrated drill ste catalog #:214227160, lot#:539310.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2018-05639.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.

Event Description

It is reported that during a procedure while the surgeon was attempting to implant the product the calibrated drill got stuck within the drill guide.There was no reported harm to the patient and the surgeon used another drill to complete the procedure successfully.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Udi : (b)(4).The reported event is confirmed.Visual inspection of the returned products noted the products were disassembled.The drill bit has a lot of damage to the a/o connect side.Also noted there is damage and a step in the guide.The photos marked shaft damage show damage to the bit probably as a result of the damage inside the guide and step.A dimensional was performed and noted the drill is conforming to specifications.The guide failed the functional check due to the step/ damage.Upon further review with the supplier, it was noted that the cannulation on these parts was completed using a two-way drill which could potentially lead to the step in the guide.Dhr was reviewed and no discrepancies relevant to the reported event were found.The root cause is determined to be a manufacturing deficiency.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: ALPS MIS DRILL GUIDE LK 2.7MM
• Type of Device: PLATE, FIXATION
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7952293
• MDR Text Key: 123262777
• Report Number: 0001825034-2018-09597
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• PMA/PMN Number: PK132898
• 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: 07/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2018
• 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: 110008317
• Device Lot Number: 047790
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1