MAUDE Adverse Event Report: ZIMMER BIOMET, INC. QUICK CONNECT GUIDE HANDLE; PROSTHESIS, SHOULDER

Model Number N/A

Device Problems Disassembly (1168); Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/06/2018

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 during the positioning of the glenoid guide during the total shoulder replacement the instrument popped.The spring and inner part fell to the floor.The doctor had already positioned the guide, so he was able to drill the guide pin and continue the surgery.No adverse effect to the case or patient was reported.When the failure occurred, the guide pin was drilled for reaming the glenoid.Attempts have been made and additional information on the reported event is unavailable.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Examination of the returned device confirms the report.The quick connect guide handle was returned for evaluation with the handle plunger fractured and disassembled.The spring and fractured portion of the plunger are not returned.The instrument showed signs of normal use.Sem analysis of the quick connect handle sample showed that its plunger suspected to be fracture due to overload.Review of device history records identified no related manufacturing deviations or anomalies that would have contributed to the reported event.Root cause was unable to 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.

• Brand Name: QUICK CONNECT GUIDE HANDLE
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7314689
• MDR Text Key: 101716909
• Report Number: 0001825034-2018-01457
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• PMA/PMN Number: PK060694
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 08/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2018
• 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: 110004319
• Device Lot Number: 250200
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2018
• Date Manufacturer Received: 08/08/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Age: 66 YR