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

Catalog Number 6704-0-520

Device Problems Break (1069); Fracture (1260); Loss of Osseointegration (2408)

Patient Problems Injury (2348); Inadequate Osseointegration (2646)

Event Date 08/07/2017

Event Type  Injury  

Manufacturer Narrative

A supplemental report will be submitted upon completion of the investigation.

Event Description

As reported in medwatch # mw5071573: total right hip arthroplasty in 2016.Patient returned to surgery in 2017 for hardware removal due to hardware failure.Hardware components loosened, fixation plate dislodged and cables around it are broken, small fragment screws seen loose in the soft tissues around the proximal femur.

Manufacturer Narrative

An event regarding loosening involving a dall miles cable, adm shell, implant plate, screw and stem was reported.The event was confirmed as the cables were damaged.Method & results: product evaluation and results: visual inspection: as per mar the devices were examined with the aid of a stereo microscope at magnifications up to 50x.To further evaluate the fracture surface of the wires, it was analyzed using a scanning electron microscope (sem).Sem analysis: sem image of the strands can be seen as ductile fracture morphologies were observed on the surface of the cable strands suggesting overload fracture.Energy-dispersive spectroscopy (eds) analysis was performed on a strand.Elemental constituents included (b)(4) which are consistent with (b)(4) alloy.Dimensional and functional inspection: could not be performed as the device was damaged upon return.Material analysis: as per mar the cable wires fractured from an overload condition in a ductile manner.Eds showed the elemental constituents to be consistent with an (b)(4) alloy.Based on the given information, no identifiable material 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.However, a review of the provided information by a clinical consultant indicated: i have seen the info for this patient with broken dall-miles cables some 1-year post implantation as total hip replacement for a hip fracture with a severe multi-fragment fracture also in the greater trochanteric (gt) area.Hip replacement was performed with a securefit stem plus an adm cup while the gt fracture was stabilized with a dall-miles plate, multiple cables plus a synthes (non-stryker) small plate and screws.At 1-year the fracture had developed into a non-union with dm-cable rupture and loose screws in and around the hip that required revision.No details about revision surgery.No x-rays are available.The mar report confirms the cable wires fractured from an overload condition in a ductile manner.Eds showed the elemental constituents to be consistent with an (b)(4) alloy.Based on the given information, no identifiable material or manufacturing discrepancies were observed on the surfaces examined.From the clinical context, it is clear that non-union of the gt-fracture was the principal failure mode.Osteosynthesis only serves primary stabilization of the fracture fragments to allow bony consolidation to occur.If the fracture is unstable, too much movement between fracture fragments prevents healing of the fracture and then the osteosynthesis material will always fail after some time due to overload, such as occurred in this patient.Why fracture healing did not occur is not clear from the information due to lack of info.Usually an adverse mix of patient-related factors (such as alcohol abuse in this patient) and procedure-related factors regarding surgical technique of fracture stabilization play an important role in fracture non-union.Exact evaluation requires x-rays that are unfortunately not available.As such can exact root cause of failure not be established due to lack of adequate information although it is certain that device-related factors did not play a role such as also confirmed by the mar findings.What the balance between patient-related and procedure-related factors has been in this case is however not clear although there is evidence that both factors have played a role that still provide a plausible explanation for the failure although full and clear evidence is missing.These gt fractures are difficult to treat and have a high complication rate and as such is this case not unusual.It should be noted that the loose screws as reported are non-stryker products as manufactured by synthes.Product 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.Conclusions: the exact cause of the event could not be determined because further information such as pre- and post-operative x-rays and the primary operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time as no devices and insufficient information were received by stryker orthopaedics.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.

Event Description

As reported in medwatch # mw5071573: total right hip arthroplasty in 2016.Patient returned to surgery in 2017 for hardware removal due to hardware failure.Hardware components loosened, fixation plate dislodged and cables around it are broken, small fragment screws seen loose in the soft tissues around the proximal femur.

• Brand Name: D-M 2.0MM BEADED CABLE SET VIT
• Type of Device: BONE FIXATION CERCLAGE
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NJ NA
• Manufacturer Contact: brian lauro ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 7006205
• MDR Text Key: 91227939
• Report Number: 0002249697-2017-03222
• Device Sequence Number: 1
• Product Code: JDQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K953818
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2021
• Device Catalogue Number: 6704-0-520
• Device Lot Number: 55828607
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/09/2017
• Initial Date FDA Received: 11/07/2017
• Supplement Dates Manufacturer Received: 01/04/2018
• Supplement Dates FDA Received: 01/31/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/25/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention