MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BMP CABLE PASSER SM; BMP CABLE SYSTEM

Model Number N/A

Device Problems Difficult to Insert (1316); Incorrect Device Or Component Shipped (2962)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Per results relayed "review of dhr and inspection records found no nonconformities.Inspection of the instrument for functional test did show that a cable did catch about half-way into the instrument but with a little additional force the wire would pass thru.Recommendations were made to the vendor to improve outcome of drilling process to eliminate any possible mis-alignment."review of device history records found these units were released to distribution with no deviations or anomalies.Review of complaint history found no additional issues reported for this part.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

It was reported that during logistical department inspection one new instrument received.For this instrument, the batch number of the label does not match with the batch number engraved on product.On the label, the batch is 333340 and on the products the batch is 392460.Moreover it was very difficult to insert cable into the instrument.This was detected in our warehouse so there is neither patient consequences or surgical delay.

• Brand Name: BMP CABLE PASSER SM
• Type of Device: BMP CABLE SYSTEM
• 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: 6910146
• MDR Text Key: 88252153
• Report Number: 0001825034-2017-07743
• Device Sequence Number: 1
• Product Code: JDQ
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/03/2017

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: 498029
• Device Lot Number: 333340
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/10/2014
• Initial Date FDA Received: 10/03/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/07/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1