MAUDE Adverse Event Report: BIOMET UK LTD. OXF UNI I/M ROD LINK

Model Number N/A

Device Problem Device Damaged Prior to Use (2284)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/03/2018

Event Type  malfunction  

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 the im link instrument broke into two piece during insertion into the im rod.

Manufacturer Narrative

(b)(4).The product was returned to zimmer biomet for evaluation.The oxf uni i/m rod link fracture analyzed by optical and sem showed that it was a weld failure, suspected to be caused by incomplete fusion.Optical images reveal the incomplete weld fusion on the link fracture surface.It is evident that half of the rod link fracture surface consisted of incomplete fusion.Sem image revealed weld discontinuity on the link edge, which was suspected to be a major cause for the rod link weld failure.Images show thin weld metal along the link edge and machining lines on the link surface which is indicative of incomplete fusion.Eds semi-quantitative elemental analysis of the rod link sample showed that it was consistent with 17-4 ph stainless steel.By reviewing the applicable process specifications, there is no abnormal issue found during dhr review both at assembly and component levels, visual inspection is applied to ensure the welding completion and correction, all parts are conformed before releasing and meet the current spec.Product development for knees had raised an engineering change notice to improve the weld process by means of using chamfers on the butt welded piece parts to increase the penetration of the weld between the two mating parts.The affected component drawing was released in production in september 2017.

• Brand Name: OXF UNI I/M ROD LINK
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 7215574
• MDR Text Key: 98413229
• Report Number: 3002806535-2018-00155
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• PMA/PMN Number: PNA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Type of Report: Initial,Followup
• Report Date: 06/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2018
• 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: 32-422822
• Device Lot Number: ZB161001
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/04/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1