MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH D-M 2.0MM BEADED CABLE SET SS; BONE FIXATION CERCLAGE

Model Number	3704-0-050
Medical Device Problem Codes	Fracture (1260); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/07/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the device history records indicate that devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Device not available.
Event or Problem Description
The product is torn apart.Replacement was available.Surgical delay of 30 min.Not longer.
Additional Manufacturer Narrative
An event regarding crack/fracture involving a dall miles cable was reported.The event was confirmed.Method & results: device evaluation and results: visual inspection was performed as part of the material analysis report (mar), dated (b)(6) 2019.This inspection indicates that the strands of the cable were examined with the aid of a stereomicroscope at magnifications up to 50x.Images of two of the strands of the cable are provided.One image is representative of most of the strands of the cable and shows evidence of being cut by a tool.A second image shows some of the wires of the strand have been cut by a tool but other wires that were not.This strand was examined in a scanning electron microscope (sem) and indicates that most of the strands of the cable were cut using a tool.Two images show morphologies that are consistent with overload.The 7 strands of the cable are shown; the 6 outer strands and the center strand.Each strand showed the correct lay with the center strand having a right hand lay and the 6 outer strands having a left hand lay.A material analysis has been performed.The report concluded: some of the strands of the dall-miles cable fractured in overload while others were cut.Eds showed that it was consistent with an astm f1314 alloy.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.Clinician review: no medical records were received for review with a clinical consultant.Device history review: all devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there have been no other similar events for the reported lot.Conclusion: material analysis concluded that some of the strands of the dall-miles cable fractured in overload while others were cut.Eds showed that it was consistent with an astm f1314 alloy.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.The exact cause of the event could not be determined because insufficient information was provided.Additional information including operative reports needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
The product is torn apart.Replacement was available.Surgical delay of 30 min.Not longer.

• 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 Key: 9006316
• Report Number: 0002249697-2019-03189
• Device Sequence Number: 1890934
• Product Code: JDQ
• UDI-Device Identifier: 07613327036350
• UDI-Public: 07613327036350
• Combination Product (Y/N): N
• PMA/510(K) Number: K971741
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/17/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2024
• Device Model Number: 3704-0-050
• Device Catalogue Number: 3704-0-050
• Device Lot Number: 71631102
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2019
• Initial Date Received by Manufacturer: 08/16/2019
• Supplement Date Received by Manufacturer: 12/20/2019
• Initial Report FDA Received Date: 09/12/2019
• Supplement Report FDA Received Date: 01/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 64 YR