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

Model Number	N/A
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/16/2021
Type of Reportable Event	Malfunction
Additional 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 or Problem 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 or Problem 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.
Additional 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
• Common Device Name: G7 INSTRUMENTS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 12405790
• Report Number: 3002806535-2021-00369
• Device Sequence Number: 5292203
• Product Code: KWY
• UDI-Device Identifier: 05019279999408
• UDI-Public: 05019279999408
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K150522
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: 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
• Initial Date Received by Manufacturer: 08/16/2021
• Supplement Date Received by Manufacturer: 10/18/2021
• Initial Report FDA Received Date: 09/01/2021
• Supplement Report FDA Received Date: 10/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other