MAUDE Adverse Event Report: ZIMMER, INC. ELBOW TORQUE DRIVER; PROSTHESIS, ELBOW INSTRUMENT

Model Number N/A

Device Problems Device Markings/Labelling Problem (2911); Packaging Problem (3007)

Patient Problem No Patient Involvement (2645)

Event Date 06/15/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).This report is number 14 of 18 mdr supplementals filed for the product (reference 0001822565-2017-05039, 0001822565-2017-05040, 0001822565-2017-05041, 0001822565-2017-05042, 0001822565-2017-05043, 0001822565-2017-05044, 0001822565-2017-05046, 0001822565-2017-05047, 0001822565-2017-05048, 0001822565-2017-05049, 0001822565-2017-05050, 0001822565-2017-05051, 0001822565-2017-05052, 0001822565-2017-05053, 0001822565-2017-05054, 0001822565-2017-05055, 0001822565-2017-05056, 0001822565-2017-05057).Expiry date on packaging - sep 1, 2017 lot number 56613801 on instrument; lot number 56613800 on label.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 was reported the lot number was inconsistent between package and product.No patient consequences or involvement were reported as a result of the malfunction.Attempts to obtain additional information are in progress, however no further information is available at this time.

Manufacturer Narrative

The follow-up report is being submitted to relay additional information.Device manufacture date: aug 23, 2015 or oct 2, 2015.

Manufacturer Narrative

Complaint sample was evaluated and the reported event was confirmed.Investigation found that the parts became unintentionally mixed during the incoming inspection, as inspector did not properly separate and segregate the materials and the inspection procedure does not define how to properly segregate and control material during the inspection process.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.Review of the complaint history determined that no further actions are required.The root causes for the reported issue attributed to be quality system deficiency and device not manufactured by reporting firm as the device manufactured by the supplier.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.

• Brand Name: ELBOW TORQUE DRIVER
• Type of Device: PROSTHESIS, ELBOW INSTRUMENT
• Manufacturer (Section D): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer (Section G): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6731529
• MDR Text Key: 80657015
• Report Number: 0001822565-2017-05053
• Device Sequence Number: 1
• Product Code: JDC
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: PK123862
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2017
• Device Model Number: N/A
• Device Catalogue Number: 00840108000
• Device Lot Number: 56613800
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/23/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1