MAUDE Adverse Event Report: BIOMET UK LTD. G7 HARD BEARING INST RING SZ E; G7 INSTRUMENTS

Model Number N/A

Device Problem Activation, Positioning or Separation Problem (2906)

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

Event Date 08/16/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Initial report.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 bearing inserter ring became lodged between liner and cup resulting in deformation of the ring.Another instrument was readily available and opened to solve the problem resulting in a minimal delay.

Event Description

It was reported that the bearing inserter ring became lodged between liner and cup resulting in deformation of the ring.Another instrument was readily available and opened to solve the problem resulting in a minimal delay.

Manufacturer Narrative

(b)(4).This final report is being submitted to relay additional information.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 the bearing inserter ring became lodged between liner and cup resulting in deformation of the ring.Another instrument was readily available and opened to solve the problem resulting in a minimal delay.Event occurred during surgery.No health consequences or impact.The evaluation of the returned product confirms that the ring was deformed.Visual inspection of the reported event showed indentations on the top face and the side of the ring.The ring was damaged and deformed on the diameter and on the top face.In addition, the instrument shows signs of wear & tear which can be expected with repeated use, reprocessing and time in field (approximately 5 years).Dimensional check was not carried out as the instrument was damaged on return.Check not required as component was not a part of an assembly.Review of declaration of compliance for radel r-5500 purple vt2582 from maitland engineering inc confirms that the material used to produce the instrument was conforming to standards and specification prior to shipment to zb.A review of the certificate of conformance from maitland engineering inc confirms that the ring was processed and verified in line with the specification and quality characteristics as defined by zimmer biomet.The product item no.110026854 has not been involved in any previous field actions.The root cause cannot be confirmed with the available information however, the likely root cause of the reported event is misuse by the user.The resulting forces that were applied to the ring, which was incorrectly seated, caused the lodging of the ring between the liner and the shell and the subsequent deformation and indentations.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 negligible.Capa: no corrective or preventive action required at this time.Investigation is completed based on current available information.If any additional information becomes available, then the complaint will be reopened and investigated.

• Brand Name: G7 HARD BEARING INST RING SZ E
• Type of Device: G7 INSTRUMENTS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 12405790
• MDR Text Key: 269370518
• Report Number: 3002806535-2021-00369
• Device Sequence Number: 1
• Product Code: KWY
• UDI-Device Identifier: 05019279999408
• UDI-Public: 05019279999408
• Combination Product (y/n): N
• PMA/PMN Number: K150522
• 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: 10/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2021
• 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: 110026854
• Device Lot Number: 579670
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other