MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PIN 2.5 MM DIAMETER; FIXATION, FASNTENER

Model Number N/A

Device Problem Fracture (1260)

Patient Problem Foreign Body In Patient (2687)

Event Date 05/19/2021

Event Type  Injury  

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 while inserting the tm reverse 2.5mm pin in a tm reverse shoulder the pin snapped at the threads.The surgeon attempted to remove the piece that snapped off but was unable to remove the piece that was left in the glenoid vault.Attempts have been made and there is no further information at this time.

Manufacturer Narrative

Cmp- (b)(4).Reported event was confirmed, as visual examination show the thread form is fractured and missing.Circumferential grooves are seen near the fracture site.The diameter of the pin is conforming to print specifications.Device history record was reviewed, and no discrepancies relevant to the reported event were found.A definitive root cause could not be determined.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.

• Brand Name: PIN 2.5 MM DIAMETER
• Type of Device: FIXATION, FASNTENER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11967558
• MDR Text Key: 255157208
• Report Number: 0001822565-2021-01593
• Device Sequence Number: 1
• Product Code: HSD
• Combination Product (y/n): N
• PMA/PMN Number: K121543
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/06/2020
• Device Model Number: N/A
• Device Catalogue Number: 47430902501
• Device Lot Number: 64658257
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other