MAUDE Adverse Event Report: BIOMET UK LTD. OXF ANAT BRG LT SM SIZE 3 PMA SML SZ 3; KNEE PROTHESIS

Model Number N/A

Device Problems Problem with Sterilization (1596); Manufacturing, Packaging or Shipping Problem (2975)

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

Event Date 02/17/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Initial report.Report source, foreign - event occurred in (b)(6).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a supplemental mdr will be submitted.

Event Description

During surgery, it was reported that a black foreign substance was found on sterile pouch.

Event Description

During surgery, it was reported that a black foreign substance was found on sterile pouch.

Manufacturer Narrative

(b)(4).Report source, foreign - event occurred in (b)(6).Products have been returned to biomet uk ltd for evaluation and forwarded to the product evaluation complaints engineer for investigation.The event reports that there was debris inside the inner sterile packaging (pouch).This was identified during surgery.No further harm has been reported.The complaint has been confirmed following review of the returned packaging which confirms there is foreign debris inside the inner sterile packaging (pouch).The pouch remains sealed.The foreign debris is a black fibre.The work instruction for the operation where the manufacturing deviation is likely to have occurred was reviewed and found to provide adequate information informing the operator to inspect packaging for foreign material inside the sterile packaging.A review of the device history records did not identify any discrepancies that would have contributed to the reported event.A complaint history review identified no similar complaints for the same item number.A complaint history review identified no similar complaints for the same lot number.The severity of the reported event and the calculated occurrence for all similar events in the last 3 years are in line with this risk file.The overall risk score is low risk.This devices is used for treatment.The reported event is not related to a combination of products; therefore, a compatibility review is not applicable.The likely condition of the device when it left zimmer biomet is non-conforming to specification.The root cause of the reported event is the operator not following the work instructions provided.This is a manufacturing deficiency.Corrective and preventive actions: issue evaluation ie-13975 has been raised to further investigate the reported event 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 ANAT BRG LT SM SIZE 3 PMA SML SZ 3
• Type of Device: KNEE PROTHESIS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 9841362
• MDR Text Key: 199063905
• Report Number: 3002806535-2020-00146
• Device Sequence Number: 1
• Product Code: NRA
• UDI-Device Identifier: 05019279785865
• UDI-Public: 05019279785865
• Combination Product (y/n): N
• PMA/PMN Number: P01004
• 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: 07/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2020
• 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: 159540
• Device Lot Number: 6680644
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other