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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET UK LTD. OXFORD SPHER CUTTER XL; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
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BIOMET UK LTD. OXFORD SPHER CUTTER XL; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT Back to Search Results
Model Number N/A
Device Problems Break (1069); Fracture (1260)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)
Event Date 05/03/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).Foreign source: (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 Description
It was reported by the hospital that during a partial knee replacement procedure the oxford spherical cutter size xl fractured.The surgeon was unable to use it, therefore another instrument, size l, was used to complete the procedure.
 
Event Description
It was reported by the hospital that during a partial knee replacement procedure the oxford spherical cutter size xl fractured.The surgeon was unable to use it, therefore another instrument, size l, was used to complete the procedure.No parts remain in patients wound.
 
Manufacturer Narrative
(b)(4).This final report is being submitted to relay additional information.The following sections were updated: b4, b5, d10, g4, g7, h1, h2, h3, h4, h6, h10.G3: report source, foreign - event occurred in netherlands.-products have been returned to biomet uk ltd for evaluation and forwarded to a research engineer for investigation - an oxford spherical cutter was returned due to fracture after a maximum time in use of 7 years.The fracture surfaces on the received components suggest that the fracture occurred suddenly, as opposed to fracture due to fatigue.- the available relevant manufacturing history records indicate that the item was manufactured and sterilised in accordance with the applicable specifications.- the reported event did not cause a significant delay to the surgery or any other complication.The ultimate reason for the fracture of the oxford spherical cutter cannot be determined with the information available at the time of writing this report.-a review of the complaint database over the last 3 years has found no similar complaints reported with the item.- the available mhr reviews indicates that the product was most likely conforming to design specification when it left zimmer biomet control, however it is not possible to confirm the root cause of the revision with the information available.Risk assessment: the event reports instrument fracture.Risk management report documents the estimated residual risk associated with the device within the reported event.The details of the reported event do not allege that there was any patient harm or delay to surgery.Therefore, the severity is considered s-1 (negligible) as per definitions within the severity table in the attached rmr.The reported event is considered to be within the severity of the rmr.In order to calculate the occurrence rate, sales and complaint data for this item number have been obtained, and are attached for a period of the last 3 years prior to notification date, being may 2019.- sales (may 2016 to may 2019) = 1873 units.- complaints search was conducted for events occurring between may 2016 to may 2019 for item 32-420332.- no other similar complaints were identified for this item number other than cmp-0499604.- therefore, the calculated occurrence rate is 1 in 1873 or 0.05%.- this is considered an acceptable occurrence rate as per the rmf which estimates an acceptable occurrence rate of 3 occasional (0.05% is considered an occurrence score of 2 remote: 0.001% - 0.01%).- since the instrument in question is reusable, number of uses is better represented by the sales of the compatible implants.-therefore, the sales for all compatible oxford knee system item has been obtained and used to calculate occurrence.Corrective and preventive actions: no corrective or preventive actions are considered necessary at this time if any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
 
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Brand Name
OXFORD SPHER CUTTER XL
Type of Device
ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Manufacturer (Section D)
BIOMET UK LTD.
waterton industrial estates
bridgend CF31 3XA
UK  CF31 3XA
MDR Report Key8623409
MDR Text Key145493168
Report Number3002806535-2019-00465
Device Sequence Number1
Product Code HXC
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Type of Report Initial,Followup
Report Date 08/07/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/20/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue Number32-420332
Device Lot NumberZB110102
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/15/2019
Was the Report Sent to FDA? No
Date Manufacturer Received08/06/2020
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
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