MAUDE Adverse Event Report: BIOMET UK LTD. OXF MP SLOT POST CUT GD MED; BMET GENERAL KNEE INSTRUMENTS

Model Number	N/A
Medical Device Problem Codes	Fracture (1260); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/11/2021
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported that during surgery, the large peg broken off posterior femoral cutter jig instrument code 32-422981 medium.
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 during surgery, the large peg broken off posterior femoral cutter jig instrument code 32-422981 medium.Event occurred during surgery.No health consequences or impact.Review of returned product confirms the reported event that the large pin has fractured.Visual inspection of the confirms that the large pin is fractured.There is evidence of brittle fracture at the point where the small diameter meets the large diameter.In addition to the fractured pin, the condition of the block indicates that the instrument has been used in multiple surgeries and as a result has multiple indentations and scratches.Slight discoloration is visible on the instrument¿s surface which is expected and in line with the length of time in the field (approximately 7 years and 6 months).Dimensional check not required as any dimensional non-conformance would impact the complaint.No assembly checks carried out as the instrument was returned damaged.A review of the raw material certificates confirms conformance to specification.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.The root cause cannot be confirmed with the available information however, the likely root cause of the reported event is damage caused by repeated use during repeated use and time spent in the field (approximately 7 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 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.No corrective actions are required at this time.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.
Event or Problem Description
It was reported that during surgery, the large peg broken off posterior femoral cutter jig instrument code 32-422981 medium.

• Brand Name: OXF MP SLOT POST CUT GD MED
• Common Device Name: BMET GENERAL KNEE INSTRUMENTS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 12115977
• Report Number: 3002806535-2021-00293
• Device Sequence Number: 4429609
• Product Code: HXC
• UDI-Device Identifier: 05019279440023
• UDI-Public: 05019279440023
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/15/2021

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: 32-422981
• Device Lot Number: ZB140102
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/14/2021
• Supplement Date Received by Manufacturer: 09/13/2021
• Initial Report FDA Received Date: 07/05/2021
• Supplement Report FDA Received Date: 09/15/2021
• 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