MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 25MM COMP RVS GLEN TRAY IMPTR; INSTRUMENT, SHOULDER

Model Number N/A

Device Problems Fracture (1260); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/23/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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 the mini baseplate inserter fractured during an initial shoulder arthroplasty.No patient harm was reported.Attempts have been made and no additional information is available at this time.

Event Description

No additional event information to report at this time.

Manufacturer Narrative

Complaint sample was returned and evaluated against the reported event.Visual examination of the returned product identified the part to have strike marks, heavy scratches, dings and gouges.It is confirmed that the part is broken and not fractured.The receiving end of the threads are damaged causing the strike plate to be screwed in incorrectly.Visual inspection of the returned product to verify item number.The lot number is etched on the part but the area where it is etched has been damaged making it illegible to read.Dhr was unable to be reviewed as the lot number for the device is unknown.The root cause of the reported issue is attributed to user error, the product is cross threaded which can only happen if it has been disassembled and this device is not to be disassembled.A summary of the investigation findings were sent to the customer.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.

Manufacturer Narrative

(b)(4).Upon receipt of additional information, it has been determined that this device did not cause or contribute to a sentinel event.

Event Description

Upon receipt of additional information, it has been determined that this device did not cause or contribute to a sentinel event.

• Brand Name: 25MM COMP RVS GLEN TRAY IMPTR
• Type of Device: INSTRUMENT, SHOULDER
• 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: 10673091
• MDR Text Key: 211461995
• Report Number: 0001825034-2020-03801
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 07/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2020
• 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: 405809
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2020
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/12/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Age: 75 YR