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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH D-M 2.0MM BEADED CABLE SET VIT; CERCLAGE, FIXATION
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STRYKER ORTHOPAEDICS-MAHWAH D-M 2.0MM BEADED CABLE SET VIT; CERCLAGE, FIXATION Back to Search Results
Model Number 6704-0-520
Device Problem Fracture (1260)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/03/2020
Event Type  malfunction  
Manufacturer Narrative
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
During a primary surgery, 2 separate dall miles cables with different lot codes broke during surgery.Surgical delay 1min, surgery completed successfully.Photos and device not available.No further information available due to hospital policy.
 
Manufacturer Narrative
Updated the lot number, manufacturing and expiration date.Reported event: an event regarding crack/fracture involving a dall miles cables was reported.The event was not confirmed.Method & results: device evaluation and results: not performed because product was not returned.Clinician review: no medical records were received for review with a clinical consultant.Product history review: review of device history records found the devices in the reported lot were accepted into final stock with no reported discrepancies.Complaint history review: the complaint databases show there have been no other events for the reported lot.Conclusion: it was reported that the patient had a surgical delay due to crack/fracture involving a dall miles cables.The exact cause of the event could not be determined because no further investigation for this event is possible at this time as no devices was received by stryker orthopaedics.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.H3 other text : device not returned.
 
Event Description
During a primary surgery, 2 separate dall miles cables with different lot codes broke during surgery.Surgical delay 1min, surgery completed successfully.Photos and device not available.No further information available due to hospital policy.
 
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Brand Name
D-M 2.0MM BEADED CABLE SET VIT
Type of Device
CERCLAGE, FIXATION
Manufacturer (Section D)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
MDR Report Key9973186
MDR Text Key188198995
Report Number0002249697-2020-00765
Device Sequence Number1
Product Code JDQ
UDI-Device Identifier07613327036466
UDI-Public07613327036466
Combination Product (y/n)N
PMA/PMN Number
K953818
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other
Type of Report Initial,Followup
Report Date 06/26/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/17/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number6704-0-520
Device Catalogue Number6704-0-520
Device Lot Number72984804
Was Device Available for Evaluation? No
Date Manufacturer Received06/05/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age70 YR
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