• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET UK LTD. OXF CMNTLS IMPLANT INSERT; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BIOMET UK LTD. OXF CMNTLS IMPLANT INSERT; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT Back to Search Results
Model Number N/A
Device Problems Break (1069); Fracture (1260)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/28/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).Report source, foreign - event occurred in (b)(6).Customer has indicated that the product is in the process of being returned to zimmer biomet for investigation.Once the investigation is complete, a supplemental mdr will be submitted.The investigation is in process.Once the investigation is complete, a follow-up mdr will be submitted.
 
Event Description
It was reported that during surgery the sales agent noticed that the impactor was broken (holder missing).No impact for surgery and another instrument used.
 
Manufacturer Narrative
(b)(4).This final report is being submitted to relay additional information.The following sections were updated: b4, b5, d10, g3, g4, g7, h1, h2, h3, h6, h10.G3: report source, foreign - event occurred in france.D10: the product has been returned to zimmer biomet for investigation.The mhr does not show any non-conformity, rejection or concession that could be related to the reported event.Visual inspection confirmed the reported event.The posterior foot is fractured.The fractured part has not been returned.The dents on the superior handle surface and the tarnish of the instrument¿s body indicate that the instrument has been used multiple times.The inferior surface of the handle has dents that indicate that the inserter was used to remove a partially or fully seated implant, by impacting an internal surface in a direction up and away from the patient.This exerted the loading on the hook, which is not designed to sustain it.Both blue replaceable plugs were returned.The memorandum from the development team attached in the hhe details possible misuse scenarios in which the posterior tab may be subjected to loading that could have caused the reported fracture.These scenarios are: 1)use of the inserter to fully impact the device, resulting in posterior tab becoming trapped between the bone and implant.2) use of excessive force when tightening the thumbwheel may lead to high anterior-posterior loading on the posterior tab.3)use of the inserter to remove a partially or fully seated implant, by impacting an internal surface in a direction up and away from the patient; 180deg.Opposite to the impaction required for the insertion.The instructions for reusable surgical instruments, doc.No.(b)(4) version 2.3 (march 2009), warns that: ¿¿maintenance, inspection and functional testing: all instruments should be visually checked for damage and wear.Cutting edges should be free of nicks and present a continuous edge.¿¿ reusable instrument lifespan manual (219.3-glbl-en-rev0419) provides verbal and visual instruction on how to detect instrument fracture.Surgical technique 0338.2-emea-en contains the following instructions: ¿¿the knee is flexed fully and, using the toffee mallet, the component is then carefully impacted¿before it is fully seated, the introducer/impactor is removed by unscrewing the thumbwheel.¿¿ ¿¿final impaction of the tibial component is achieved with the toffee mallet and the standard impactor placed centrally over the knee¿¿.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.
 
Event Description
Before the surgery, the sales agent noticed that the impactor was broken, a holder is missing.There was no impact for the surgery as they used another one from another set.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
OXF CMNTLS IMPLANT INSERT
Type of Device
ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Manufacturer (Section D)
BIOMET UK LTD.
waterton industrial estates
bridgend CF31 3XA
UK  CF31 3XA
MDR Report Key9479821
MDR Text Key191452261
Report Number3002806535-2019-00927
Device Sequence Number1
Product Code NRA
Combination Product (y/n)N
PMA/PMN Number
P010014
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 02/29/2020
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
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue Number32-422097
Device Lot NumberZB151101
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/04/2020
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 11/28/2019
Initial Date FDA Received12/17/2019
Supplement Dates Manufacturer Received02/12/2020
Supplement Dates FDA Received02/29/2020
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
-
-