MAUDE Adverse Event Report: BIOMET UK LTD. OXF TIB RESECT STYLUS ASSY 4MM; PROSTHESIS, KNEE

Catalog Number 32-422863

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/01/2018

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.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that top screw of the g clamp was loose where normally it is welded with epoxy coating.During surgery it caused difficulty while attaching the g clamp to the oxford® tibial gap sizing spoon (32-422792).Surgeon succeeded finally to attach the g clamp to the spoon.No harm to the patient reported.

Manufacturer Narrative

(b)(4).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that top screw of the g clamp was loose where normally it is welded with epoxy coating.During surgery it caused difficulty while attaching the g clamp to the oxford® tibial gap sizing spoon (32-422792).Surgeon succeeded finally to attach the g clamp to the spoon.No harm to the patient reported.

Manufacturer Narrative

(b)(4).Device history record (dhr) was reviewed and no discrepancies were found.Visual inspection confirmed the reported event.The screw of the item became loose as a result the assembly has disintegrated.The screw is set at 3.1mm from its base point for accurate alignment during surgery, therefore, the instrument lost the manufactured gap tolerance.The failure could have been caused by the attempts to undo the screw by cleaning technician for reprocessing, high autoclave temperatures, multiple sterilisation cycles and/or repeated use.However, the contribution of these factors cannot be confirmed by the information provided in the complaint or visual analysis.The product development team has implemented a change - ecr 0741 ((b)(6) 2017), to address this issue.The current design version 32-422846-f utilises a pin to secure the screw in position.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

It was reported that top screw of the g clamp was loose where normally it is welded with epoxy coating.During surgery it caused difficulty while attaching the g clamp to the oxford® tibial gap sizing spoon (32-422792).Surgeon succeeded finally to attach the g clamp to the spoon.No harm to the patient reported.

• Brand Name: OXF TIB RESECT STYLUS ASSY 4MM
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 8058965
• MDR Text Key: 127355965
• Report Number: 3002806535-2018-01188
• Device Sequence Number: 1
• Product Code: NRA
• Combination Product (y/n): N
• PMA/PMN Number: P010014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 11/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 32-422863
• Device Lot Number: ZB130501
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1