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

Catalog Number 3704-0-050

Device Problem Device Difficult to Setup or Prepare (1487)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/25/2018

Event Type  malfunction  

Manufacturer Narrative

It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.

Event Description

Attempted to pass the dole miles cable sleeve set 2.0 mm through a single tensioner, but it does not pass, but it passes through when replacing to 1.6 mm, so it corresponds at 1.6 mm.

Manufacturer Narrative

An event regarding an assembly issue involving a dall miles cable was reported.The event was not confirmed.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Further information such as device return, device lot details and operative reports would be helpful in investigating this event further.If additional information and/or device become available, this investigation will be reopened.

Event Description

Attempted to pass the dole miles cable sleeve set 2.0 mm through a single tensioner, but it does not pass, but it passes through when replacing to 1.6 mm, so it corresponds at 1.6 mm.

• Brand Name: D-M 2.0MM BEADED CABLE SET SS
• Type of Device: CERCLAGE, FIXATION
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 7532759
• MDR Text Key: 108857525
• Report Number: 0002249697-2018-01508
• Device Sequence Number: 1
• Product Code: JDQ
• Combination Product (y/n): N
• PMA/PMN Number: K971741
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 07/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 3704-0-050
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other