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

Catalog Number	3704-0-050
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/12/2019
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.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
Breaking the dall miles cable during implanting; another cable needed.Update: "patient has reported the symptoms of pain within the proximal femur; the imaging showed a rupture of the bone and distal migration of the stem; revision treatment with the aesculap revision function and stryker dall miles system - one of the cables sprang up during tensioning.Replaced with another cable.No additional comments.Condition of the patient after the surgery very good - broken cable successfully replaced.".
Additional Manufacturer Narrative
An event regarding crack/fracture involving a dall miles cable was reported.The event was confirmed after examination of the returned device.Method & results: product evaluation and results: visual inspection was performed as part of the material analysis report (mar), dated 29 apr 2019.This inspection indicated: the returned device showed the respective fracture surfaces.Due to the size of the individual fracture surfaces no additional visual analysis was performed.Material analysis of the returned device noted the following: the dall-miles cable fractured in overload and 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.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.Conclusions: material analysis of the returned device concluded that the dall-miles cable fractured in overload and 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.Further information such as the primary operative report is 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
Breaking the dall miles cabele during implanting (ref: 3704-0-050, lot: 69107907); surgery id: (b)(6); another cabel needed.Update: "patient has reported the symptoms of pain within the proximal femur; the imaging showed a rupture of the bone and distal migration of the stem; revision treatment with the aesculap revision function and stryker dall miles system - one of the cables sprang up during tensioning.Replaced with another cable.No additional comments.Condition of the patient after the surgery very good - broken cable successfully replaced." left side; surgical delay: 10 min.

• Brand Name: D-M 2.0MM BEADED CABLE SET SS
• Common Device Name: CERCLAGE, FIXATION
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 8493259
• Report Number: 0002249697-2019-01564
• Device Sequence Number: 1471230
• Product Code: JDQ
• UDI-Device Identifier: 07613327036350
• UDI-Public: 07613327036350
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K971741
• 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): 06/14/2019

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: 12/31/2023
• Device Catalogue Number: 3704-0-050
• Device Lot Number: 69107907
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2019
• Initial Date Received by Manufacturer: 03/12/2019
• Supplement Date Received by Manufacturer: 05/20/2019
• Initial Report FDA Received Date: 04/08/2019
• Supplement Report FDA Received Date: 06/14/2019
• 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: 40 YR
• Patient Weight: 75