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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH DALL MILES VIT 2.0MM CABLE; CERCLAGE, FIXATION
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STRYKER ORTHOPAEDICS-MAHWAH DALL MILES VIT 2.0MM CABLE; CERCLAGE, FIXATION Back to Search Results
Catalog Number 6704-8-240
Device Problems Fracture (1260); Device Difficult to Setup or Prepare (1487)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/18/2020
Event Type  malfunction  
Manufacturer Narrative
Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.
 
Event Description
On tightening a dall miles cable with a double sided tensioner through a medium troch grip, the surgeon noted the cable started to break.This required the opening of a new cable.The cable was frayed near the edge of the grip.The surgeon is experienced and has been using these cables for 20 years.He used his usual technique.Surgical delay: 5 minute delay to open and apply another cable.
 
Event Description
On tightening a dall miles cable with a double sided tensioner through a medium troch grip, the surgeon noted the cable started to break.This required the opening of a new cable.The cable was frayed near the edge of the grip.The surgeon is experienced and has been using these cables for 20 years.He used his usual technique.Surgical delay: 5 minute delay to open and apply another cable.
 
Manufacturer Narrative
Reported event: an event regarding crack/fracture involving a dall miles cable was reported.The event was confirmed through material analysis evaluation of the returned device.Method & results: product evaluation and results: the dall miles cable was returned for evaluation.The strands of the cable appear fractured.Material evaluation was completed and indicated the following comments: the dall miles cable was returned with fractured strands, the cable was examined with the aid of a scanning electron microscope.The fracture is consistent with an overload fracture as indicated by the dimple fracture morphology.Energy dispersive spectroscopy was performed on the fractured component and confirmed it was consistent with a astm f90 alloy (co-cr-w-ni-mn), which is consistent with the drawing.Based on the given information no materials or manufacturing discrepancies were observed on the surfaces examined.Medical records received and evaluation: no medical records were received for review with a clinical consultant.Product history review: a review of the device manufacturing records indicate that all devices accepted into final stock were free from discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusion: the dall miles cable was returned for evaluation.The strands of the cable appear fractured.Material evaluation was completed and indicated the following comments: the dall miles cable was returned with fractured strands, the cable was examined with the aid of a scanning electron microscope.The fracture is consistent with an overload fracture as indicated by the dimple fracture morphology.Energy dispersive spectroscopy was performed on the fractured component and confirmed it was consistent with a astm f90 alloy (co-cr-w-ni-mn), which is consistent with the drawing.Based on the given information no materials or manufacturing discrepancies were observed on the surfaces examined.No further investigation for this event is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
 
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Brand Name
DALL MILES VIT 2.0MM CABLE
Type of Device
CERCLAGE, FIXATION
Manufacturer (Section D)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
MDR Report Key10250376
MDR Text Key198126103
Report Number0002249697-2020-01397
Device Sequence Number1
Product Code JDQ
Combination Product (y/n)N
PMA/PMN Number
K945294
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other
Type of Report Initial,Followup
Report Date 11/06/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/09/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date04/30/2024
Device Catalogue Number6704-8-240
Device Lot Number71456009
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/29/2020
Date Manufacturer Received10/12/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age49 YR
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