MAUDE Adverse Event Report: ZIMMER BIOMET, INC. EXPLOR 7X26MM IMPL STEM W/SCR; ELBOW PROSTHESIS

Model Number N/A

Device Problem Component Missing (2306)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/09/2015

Event Type  malfunction  

Manufacturer Narrative

Reported event was unable to be confirmed due to limited information received from the customer.Review of the complaint history determined that no further action is required as no were trends identified.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.Completion of the investigation relayed to the sales rep via phone.Complaint out of box(coob) cannot be confirmed.Review of dhr shows the correct amount of screws were issued to the order; therefore we would determine that product left biomet conforming.In addition, 10 units have been invoiced as implanted with no additional concerns of this nature reported.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 a procedure on (b)(6) 2015, the rep opened the explor stem with set screw.The scrub tech could not find the set screw, nor could the rep.The surgeon was ready for implantation, so the rep had to open up a single implant locking screw.After the case, the box was gone through, and the sterile table was looked over to see if the set screw could be located.It was never found.No additional patient consequences were reported.

• Brand Name: EXPLOR 7X26MM IMPL STEM W/SCR
• Type of Device: ELBOW PROSTHESIS
• 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: 6909177
• MDR Text Key: 89524547
• Report Number: 0001825034-2017-07757
• Device Sequence Number: 1
• Product Code: KWI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK040611
• 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: 10/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2017
• 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: 11-210062
• Device Lot Number: 052540
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/17/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/03/2015
• 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
• Patient Age: 39 YR