MAUDE Adverse Event Report: BIOMET 3I DO NOT UE-CERTAIN® RATCHET EXTENSION - SHORT 4.1, 5.0, 6.0MM(D)

Catalog Number IRE100

Device Problem Mechanical Problem (1384)

Patient Problem No Information (3190)

Event Date 08/13/2019

Event Type  malfunction  

Manufacturer Narrative

The device is not going to be returned by the reporter (device still in use).

Event Description

It was reported that the ratchet extension dropped the implant during the implant placement, an other implant was placed during the procedure.

Event Description

No additional or corrected information to report.

Manufacturer Narrative

This report is being submitted to relay additional information.The following sections are being reported: b4: date of this report was updated.D1 brand name was updated.D4: catalog number was added.G4: date received by manufacturer was updated.G7: type of report was updated.H2: type of follow up was updated.H3: device evaluated by manufacturer was updated.H6: method code was updated to 4114.H6: results code was updated to 312.H6: conclusions code was updated to 67.H10: narrative/data was updated.The reported device was not returned for evaluation.The reported event of the ratchet extension dropping the implant was not confirmed.Since the ratchet extension has not been returned, visual/functional inspection could not be performed.Dhr review and complaint history review per lot could not be performed, as the lot number associated with the reported product is not available.Zimmer biomet quality management system (qms) has controls in place to ensure the distribution of conforming product within specifications.A complaint history review by item number was conducted for reported product dating back to 12 months from now revealed that there are no existing non-conformance/capa/hhe/d/ie/product holds for the reported device related to the reported events.A definitive root cause for the reported event could not be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: DO NOT UE-CERTAIN® RATCHET EXTENSION - SHORT 4.1, 5.0, 6.0MM(D)
• Type of Device: RATCHET EXTENSION
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 9500858
• MDR Text Key: 176271178
• Report Number: 0001038806-2019-01662
• Device Sequence Number: 1
• Product Code: NDP
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 02/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: IRE100
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/22/2019
• Initial Date FDA Received: 12/20/2019
• Supplement Dates Manufacturer Received: 02/17/2020
• Supplement Dates FDA Received: 02/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 64 YR