MAUDE Adverse Event Report: BIOMET UK LTD. OXF GAP GAUGE MED 7/8MM 8; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number N/A

Device Problem Particulates (1451)

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

Event Date 02/09/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Report source, foreign - event occurred in (b)(6).Multiple mdr reports were filed for this event, please see associated reports: 3002806535 - 2018 - 00410, 3002806535 - 2018 - 00411.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 blue spacer left plastic debris in the patient¿s wound during gap balancing procedure.

Event Description

It was reported that the blue spacer left plastic debris in the patient¿s wound during gap balancing procedure.

Manufacturer Narrative

(b)(4).Reported event was confirmed by visual inspection of the actual device.Device history record (dhr) was reviewed and no discrepancies were found.There is extensive wear evident on the flat face of the gap gauges this is most probably due to extensive use (wear and tear) as these parts were manufactured in 2014.However, the exact cause of failure cannot be determined with the information provided.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: OXF GAP GAUGE MED 7/8MM 8
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 7302127
• MDR Text Key: 101574911
• Report Number: 3002806535-2018-00412
• Device Sequence Number: 1
• Product Code: HTJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 02/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2018
• 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: 32-422808
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other