MAUDE Adverse Event Report: BIOMET UK LTD. OXF MP SLOT POST CUT GD SML

Catalog Number 32-422980

Device Problems Break (1069); Fracture (1260)

Patient Problems Pain (1994); Foreign Body In Patient (2687)

Event Date 09/03/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Report source, foreign - event occurred in (b)(6).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

During a knee arthroplasty , the colour coded pin loosened and remained in the patient's joint.The part was removed from the patient with minimal invasive surgery.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Reported event was confirmed by visual inspection.Device history record (dhr) was reviewed and no discrepancies were found.The complaint evaluation concludes that the instrument likely left zimmer biomet conforming to specification, and through routine usage and reprocessing cycles the bonding between the parts has degraded, allowing the pin to become loose from the device and fall out, subsequently the colour coding rod has also fallen out of the device.A corrective action has been implemented in (b)(6) 2018 following continuous improvement initiatives to change the method of fixation of the colour coding rod securing pin from loctite adhesive to a spot welding process to ensure the pin cannot become detached through routine cleaning and sterilization cycles performed as necessary.

Event Description

During a knee arthroplasty, the colour coded pin loosened and remained in the patient's joint.The part was removed from the patient with minimal invasive surgery.

• Brand Name: OXF MP SLOT POST CUT GD SML
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 7927291
• MDR Text Key: 122371638
• Report Number: 3002806535-2018-01113
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 02/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 32-422980
• Device Lot Number: ZB160701
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 51 YR