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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET UK LTD. OXF MP SLOT POST CUT GD LGE; KNEE ARTHROPLASTY
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BIOMET UK LTD. OXF MP SLOT POST CUT GD LGE; KNEE ARTHROPLASTY Back to Search Results
Model Number N/A
Device Problems Break (1069); Fracture (1260); Activation, Positioning or Separation Problem (2906); Compatibility Problem (2960); Material Integrity Problem (2978)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/09/2021
Event Type  malfunction  
Event 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.
 
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.
 
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 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.
 
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 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.
 
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Brand Name
OXF MP SLOT POST CUT GD LGE
Type of Device
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 Key12525380
MDR Text Key281206244
Report Number3002806535-2021-00401
Device Sequence Number1
Product Code LXH
UDI-Device Identifier05019279440030
UDI-Public05019279440030
Combination Product (y/n)N
Reporter Country CodeDA
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup,Followup
Report Date 12/20/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/24/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue Number32-422982
Device Lot NumberZB180501
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received12/15/2021
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Removal/Correction NumberN/A
Patient Sequence Number1
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