MAUDE Adverse Event Report: ZIMMER, INC. ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM INSTRUMENT - DRILL; PROSTHESIS, SHOULDER

Model Number N/A

Device Problems Component Missing (2306); Packaging Problem (3007)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/26/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Udi: (b)(4).Packaging received.The complaint device has been returned, but the device investigation has not yet been completed.Once the evaluation is completed, a supplemental medwatch 3500a will be submitted.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 stated that after removing wrapper and opening box, there was no product inside.No adverse events have been reported as a result of the malfunction.

Manufacturer Narrative

Complaint packaging was evaluated and the reported event was confirmed.The drill packaging was returned it was determined that tyvek was still sealed to the cavity and there was no product or snap-in plugs inside the sealed cavity.Dhr was reviewed and no discrepancies were found.Root cause is 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.

• Brand Name: ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM INSTRUMENT - DRILL
• Type of Device: PROSTHESIS, SHOULDER
• 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: 6819912
• MDR Text Key: 83730724
• Report Number: 0001822565-2017-06082
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK052906
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/08/2018

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: Physician
• Device Model Number: N/A
• Device Catalogue Number: 47430904601
• Device Lot Number: 63717593
• Other Device ID Number: SEE H10 NARRATIVE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/28/2017
• Initial Date FDA Received: 08/25/2017
• Supplement Dates Manufacturer Received: 03/08/2018
• Supplement Dates FDA Received: 03/09/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/17/2017
• 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