MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMPREHENSIVE SRS DISTAL BODY WITH SCREW - LEFT; ELBOW, PROSTHESIS

Model Number N/A

Device Problems Defective Device (2588); Device-Device Incompatibility (2919)

Patient Problem No Code Available (3191)

Event Date 02/08/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4) concomitant medical products: 114826, disc ulna 4x115 mm lt w/brng, 198250.The 114700, disc condyle kit w/ hexalobula, 885680.The 211252, compr srs 70 mm dst hml bdy lt, 257870.(b)(6).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 that during a total elbow reconstruction procedure, the distal humeral body, condyle kit, and ulna component were unable to be assembled.This issue was found on the back table while testing the coupling of the devices.The procedure was completed with another system, delaying the procedure greater than 60 minutes.No patient impact was reported.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was confirmed by review of product received.As returned, the humeral body and condyle were assembled together, but the hexalobular screws were not fully threaded through the condyles.There is a small gap between the condyle and humeral body, preventing the screws from seating.The products were disassembled and dimensional analysis was performed.The device was found non-conforming.Dhr was reviewed and no discrepancies were found.Investigation results concluded that the reported event was due to inadequate inspection methods.Corrective and preventive actions have been initiated.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: COMPREHENSIVE SRS DISTAL BODY WITH SCREW - LEFT
• 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: 7318193
• MDR Text Key: 101662327
• Report Number: 0001825034-2018-01591
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: PK111746
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 211252
• Device Lot Number: 257870
• Other Device ID Number: (01) 0880304540699
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/04/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/24/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-1173-2018
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 36 YR