MAUDE Adverse Event Report: BIOMET UK LTD. OXF UNI PH3 SPH CUTTER MED; BMET GENERAL KNEE INSTRUMENTS

Model Number N/A

Device Problem Material Integrity Problem (2978)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/14/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that during surgery, it was identified that the bone mill was not sharp.

Event Description

It was reported that during surgery, it was identified that the bone mill was not sharp.

Manufacturer Narrative

(b)(4).Complaint summary: products have been returned to biomet uk ltd for evaluation and forwarded to the complaints processing unit for investigation.The complaint states: it was reported that during surgery, it was identified that the bone mill was not sharp.No patient impact.No delay in surgery.Event occurred during surgery.No health consequences or impact.Review of returned product confirms the reported event.Visual inspection of the confirms that the cutting teeth are worn and chipped.The condition of the spherical cutter indicates that the cutter has been used in multiple surgeries and as a result became blunt.Slight discoloration is visible on the instruments surface which is expected and in line with the length of time in the field (approximately 6 years and 6 months).Dimensional check not required as any dimensional non-conformance would impact the complaint.No assembly checks carried out as this has no impact to the reported event.The most likely root cause of the reported event is damage caused by repeated use during repeated use and time spent in the field (approximately 6 years and 6 months).Investigation is completed based on current available information.If any additional information becomes available, then the complaint will be reopened and investigated.A review of the manufacturing history record shows that there were no recorded non-conformances during the production of the instrument and the certificate of conformance confirms that the device was processed and verified in line with the specification and quality characteristics as defined by zimmer biomet.A review of the raw material certificates confirms that material conforms to specification.A review of the complaint database did not show any capa or hhed associated to this complaint category.Both the severity and occurrence of the reported event are in line with the risk file.No harm to patient has been reported.The item was distributed conforming.Adequate instructions are provided to ensure the instrument is reprocessed correctly.The hazard and reported harm are covered by the risk file and the severity/occurrence and the risk scores are within acceptable limits.The overall risk is considered to be low.Capa: no corrective or preventive action required at this time.If any further information is found which would change or alter any conclusions or information, a supplemental will be submitted accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: OXF UNI PH3 SPH CUTTER MED
• Type of Device: BMET GENERAL KNEE INSTRUMENTS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 12115321
• MDR Text Key: 261682327
• Report Number: 3002806535-2021-00292
• Device Sequence Number: 1
• Product Code: HXC
• UDI-Device Identifier: 05019279482283
• UDI-Public: 05019279482283
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 09/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2021
• 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: 32-420330
• Device Lot Number: ZB150101
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Weight: 99