MAUDE Adverse Event Report: ZIMMER BIOMET, INC. LINER IMPACTOR 40 MM

Model Number N/A

Device Problem Fracture (1260)

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

Event Date 05/11/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).User facility report was received.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 reverse total shoulder arthroplasty, the peg on the inserter broke off following impaction.No patient consequences were reported as a result of the malfunction.Attempts have been made and no further information has been provided.

Manufacturer Narrative

(b)(4).

Event Description

No additional event information to report at this time.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

(b)(4).Reported event was confirmed by review of the product returned.Impactor was returned without the fractured post.Post is confirmed to be fractured.Dhr was reviewed and no discrepancies were found.Investigation results concluded that the reported event was due to design 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: LINER IMPACTOR 40 MM
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7656853
• MDR Text Key: 113191861
• Report Number: 0001822565-2018-03558
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• PMA/PMN Number: PNI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Type of Report: Initial,Followup,Followup
• Report Date: 03/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2018
• 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: 00430902800
• Device Lot Number: 60443178
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2019
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Date Manufacturer Received: 03/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-2212/2215-12
• Patient Sequence Number: 1
• Patient Age: 85 YR