MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BLACK MAMBA SUTURE PASSER

Model Number N/A

Device Problems Difficult or Delayed Positioning (1157); Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/13/2014

Event Type  malfunction  

Manufacturer Narrative

(b)(6).The instrument was not returned for evaluation due to being discarded.The product that exhibited the failure mode was reproduced using needles and a silicone membrane to substitute as the tissue.By using this set up the, fracture was recreated in the same location.Further investigation of the needle did not reveal any dimensional problems or manufacturing defects for the needle.Analysis of the passer showed that needle track was biased to far to one side.This would allow the needle to come out of it's track and twist.This increased the resistance or force required to "push" the needle through the tissue.This further supports the evidence that the needle is under high compression causing the needle to buckle/break.Review of the dhr found units were released for distribution with no deviation or anomaly.Review of complaint history identified associated complaint and a trend which was addressed through internal controls.The root cause was determined to be associated with failure during design verification, failure to implement appropriate inspection techniques, and incorrect prints from vendor.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.This report is being submitted late as it has been identified in remediation.Multiple mdr reports were filed for this event, please see associated reports:09985.

Event Description

It was reported that patient underwent a rotator cuff repair procedure on (b)(6) 2014 utilizing a suture passer.During the procedure, the nitinol needle fractured inside the mamba suture passer.A bipass suture passer was used to complete the procedure without significant delay.There was no injury to the patient as a result.

• Brand Name: BLACK MAMBA SUTURE PASSER
• Type of Device: PASSER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 7007517
• MDR Text Key: 92212545
• Report Number: 0001825034-2017-09986
• Device Sequence Number: 1
• Product Code: HWQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 110010849
• Device Lot Number: 169620
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/13/2014
• Initial Date FDA Received: 11/07/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/05/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Age: 64 YR