MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMPR 3-IN-1 IMPACTOR; SHOULDER, INSTRUMENT

Catalog Number 110028055

Device Problem Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/30/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Foreign report source: (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 report will be submitted.

Event Description

It was reported that the surgeon was impacting the humeral bearing very gently when the plastic tip of the impactor fractured.There was no reported patient injury.

Event Description

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

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Device history record was reviewed and no discrepancies were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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

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

Manufacturer Narrative

Visual examination of the returned product identified the tip was fractured.The device was sent for further analysis and found that the fracture likely initiated at the thread interface (possibly associated with overtightening) with fracture surface artifacts of hackle marks and river lines.It was concluded that the failure mode was likely bending overload.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: COMPR 3-IN-1 IMPACTOR
• Type of Device: SHOULDER, INSTRUMENT
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10905570
• MDR Text Key: 218665327
• Report Number: 0001825034-2020-04227
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 07/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 110028055
• Device Lot Number: 923570
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1