MAUDE Adverse Event Report: ZIMMER BIOMET, INC. CORTICAL BONE SCR 5.0MM X 34MM; PROSTHESIS, SHOULDER

Model Number N/A

Device Problems Tear, Rip or Hole in Device Packaging (2385); Difficult to Open or Remove Packaging Material (2922)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/27/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported the affixus cortical screw did not open properly.Internal package ripped upon attempting to open.Surgeon deemed item not fit for implantation in case contamination occurred.

Manufacturer Narrative

(b)(4).Reported event was considered confirmed via visual evaluation.Device history record was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause could not be determined.This event was farther investigated through the capa process.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: CORTICAL BONE SCR 5.0MM X 34MM
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10174282
• MDR Text Key: 195749989
• Report Number: 0001825034-2020-02417
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 00887868039478
• UDI-Public: (01)00887868039478(17)281206
• Combination Product (y/n): N
• PMA/PMN Number: K100238
• 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: 09/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2020
• 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: 814550034
• Device Lot Number: M18814 A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1