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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 SS; BONE FIXATION CERCLAGE
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STRYKER ORTHOPAEDICS-MAHWAH D-M 2.0MM BEADED CABLE SET SS; BONE FIXATION CERCLAGE Back to Search Results
Model Number 3704-0-050
Medical Device Problem Code Fracture (1260)
Health Effect - Clinical Code Insufficient Information (4580)
Date of Event 02/03/2021
Type of Reportable Event Malfunction
Additional 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 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.Device not returned.
 
Event or Problem Description
When tightening d/m cable with single tensioner, cable was broken inside the tensioner.Surgeon tightened as usual.
 
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Brand Name
D-M 2.0MM BEADED CABLE SET SS
Common Device Name
BONE FIXATION CERCLAGE
Manufacturer (Section D)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
MDR Report Key11396282
Report Number0002249697-2021-00354
Device Sequence Number1165179
Product Code JDQ
UDI-Device Identifier07613327036350
UDI-Public07613327036350
Combination Product (Y/N)N
Initial Reporter CountryJA
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source health professional,other
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 03/01/2021
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
Operator of Device Health Professional
Device Expiration Date10/31/2024
Device Model Number3704-0-050
Device Catalogue Number3704-0-050
Device Lot Number75395211
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 02/03/2021
Initial Report FDA Received Date03/01/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
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