MAUDE Adverse Event Report: BIOMET UK LTD. OXF MP SLOT POST CUT GD LGE; KNEE ARTHROPLASTY

Model Number	N/A
Medical Device Problem Codes	Break (1069); Fracture (1260); Activation, Positioning or Separation Problem (2906); Compatibility Problem (2960); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/09/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that: during an oxford procedure, when the surgeon was tapping in the large posterior resection guide, (32-422982), a small metal tip came loose from the instrument.The surgeon discovered it in the wound, and retrieved it before closure.The nurse was able to insert the tip into the instrument again.Patient involved.
Additional Manufacturer Narrative
(b)(4).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.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.Additional information received: item lot number: zb180501.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: during an oxford procedure, when the surgeon was tapping in the large posterior resection guide, (32-422982), a small metal tip came loose from the instrument.The surgeon discovered it in the wound, and retrieved it before closure.The nurse was able to insert the tip into the instrument again.Patient involved.
Additional Manufacturer Narrative
Cmp-(b)(4).Complaint summary: it was reported that: during an oxford procedure, when the surgeon was tapping in the large posterior resection guide, (32-422982), a small metal tip fractured from the instrument.The surgeon discovered it in the wound, and retrieved it before closure.The nurse was able to insert the tip into the instrument again.Patient involvement - no impact on the patient.Occurred during surgical procedure.A visual check of the returned product oxford mp slot post cutting guide large (item 32-422982, lot.Zb180501) shows that the instrument has surface damage consistent with use in the field for 3 years, but no evidence of the reported problem with the small metal tip.The complete assembly is secure with no loose parts.A dimensional inspection is not required for this event as this reported event is for a fractured pin.The oxford mp slot post cutting guide large (item 32-422982, lot.Zb180501) has been inspected and no defect relating to the reported event can be found therefore the root cause cannot be established as the complaint is unconfirmed.The product left zimmer biomet control conforming.The severity of the reported event for similar complaints are in line with the risk file.The overall score is low risk.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.
Event or Problem Description
It was reported that: during an oxford procedure, when the surgeon was tapping in the large posterior resection guide, (32-422982), a small metal tip fractured from the instrument.The surgeon discovered it in the wound, and retrieved it before closure.The nurse was able to insert the tip into the instrument again.Patient involved.

• Brand Name: OXF MP SLOT POST CUT GD LGE
• Common Device Name: KNEE ARTHROPLASTY
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• Manufacturer (Section G): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 12525380
• Report Number: 3002806535-2021-00401
• Device Sequence Number: 4094781
• Product Code: LXH
• UDI-Device Identifier: 05019279440030
• UDI-Public: 05019279440030
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/20/2021

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: 32-422982
• Device Lot Number: ZB180501
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/10/2021
• Supplement Date Received by Manufacturer: 11/02/2021; 12/15/2021
• Initial Report FDA Received Date: 09/24/2021
• Supplement Report FDA Received Date: 11/02/2021; 12/20/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• 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
• Patient Sex: Unknown