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

Catalog Number 3704-0-050

Device Problems Component Missing (2306); Manufacturing, Packaging or Shipping Problem (2975); Packaging Problem (3007)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/16/2016

Event Type  malfunction  

Manufacturer Narrative

When completed, the investigation results will be submitted in a supplemental report.

Event Description

Customer has reported to sales rep (b)(6) that the boxes with dall miles were empty when opening.This was discovered during surgery (b)(6) but not reported to stryker before today 30th of september.The surgery proceeded by using other implants available.No consequences for patient reported.

Manufacturer Narrative

An event regarding a packaging issue involving a d-m 2.0mm beaded cable set ss was reported.The event was not confirmed.Method & results: device evaluation and results: visual inspection of the returned packaging found nothing remarkable with the packaging , both returned packages had the ifu inside.Medical records received and evaluation: not performed as no medical records were received for review with a clinical consultant.Note : there was no indication of patient involvement in this issue.Device history review: indicated that the specified lot was accepted into final stock with no reported discrepancies.Complaint history review: indicated that there have not been any other events for the specified lot.Conclusions: a review of the returned device and manufacturing process was carried out by the manufacturing engineer and quality engineer.The report concluded : "it can be concluded that there are adequate controls in place to ensure that the product is correctly packaged and labelled prior to being released into the field and that the issue was not generated through the packaging manufacturing process".No further investigation for this event is possible at this time.If additional information becomes available, this investigation will be reopened.

Event Description

Customer has reported to sales rep (b)(6) that the boxes with dall miles were empty when opening.This was discovered during surgery (b)(6) but not reported to stryker before today (b)(6).The surgery proceeded by using other implants available.No consequences for patient reported.

• 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
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NA
• Manufacturer Contact: cindy chuhinko ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6063638
• MDR Text Key: 59011786
• Report Number: 0002249697-2016-03381
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2021
• Device Catalogue Number: 3704-0-050
• Device Lot Number: 55999703
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/29/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/28/2016
• 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): Other