MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH D-M 1.6MM BEADED CABLE SET VIT; CERCLAGE, FIXATION

Catalog Number	6704-0-420
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/29/2019
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
During surgery, the wire was broken when the surgeon applied tension to the wire.Update: 2-3 minutes surgical delay.Left side.
Event or Problem Description
During surgery, the wire was broken when the surgeon applied tension to the wire.Update: 2-3 minutes surgical delay.Left side.
Additional Manufacturer Narrative
An event regarding crack/fracture involving a dall miles cable was reported.The event was confirmed by mar.Method & results: -device evaluation and results: visual inspection: visual inspection was performed as part of the material analysis report (mar), dated 03 june 2019.This inspection indicated: due to the size of the individual fracture surfaces no additional visual analysis was performed.Additional analysis was performed on fracture surfaces a & b using a scanning electron microscope (sem).Sem analysis: post-fracture abrasion obscured a portion of each fracture surface.Morphologies are consistent with overload.Fracture surface shows the 7 strands of the cable, 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.Dimensional & functional inspection: not performed as the device was returned damaged and in its current condition would not be an accurate reflection of its original manufactured condition.Material analysis a material analysis has been performed.The report concluded: the dall-miles cable fractured in overload and eds showed that it was consistent with an astm f90 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: event confirmed & root cause identified: the investigation concluded that the dall-miles cable fractured in overload and eds showed that it was consistent with an astm f90 alloy.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.

• Brand Name: D-M 1.6MM BEADED CABLE SET VIT
• Common Device Name: CERCLAGE, FIXATION
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 8557772
• Report Number: 0002249697-2019-01743
• Device Sequence Number: 2443436
• Product Code: JDQ
• UDI-Device Identifier: 07613327036435
• UDI-Public: 07613327036435
• Combination Product (Y/N): N
• PMA/510(K) Number: K953818
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/03/2019

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: 07/31/2023
• Device Catalogue Number: 6704-0-420
• Device Lot Number: 66288705
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/29/2019
• Supplement Date Received by Manufacturer: 06/11/2019
• Initial Report FDA Received Date: 04/26/2019
• Supplement Report FDA Received Date: 07/03/2019
• 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: 86 YR
• Patient Weight: 43