MAUDE Adverse Event Report: STRYKER ORTHOBIOLOGICS-MALVERN PETITE NASAL DORSUM SIZER SET; INSTRUMENT

Catalog Number 85000

Device Problems Device Reprocessing Problem (1091); Nonstandard Device (1420); Delivered as Unsterile Product (1421)

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

Event Date 12/06/2016

Event Type  malfunction  

Manufacturer Narrative

Even though the device is not available for evaluation, the label error has been identified and the associated lots placed on a global product hold.(b)(4) has been initiated and additional information will be added to this report, when available.Product is being used - only a label issue.

Event Description

It was reported by the quality officer that the non-sterile stent sizers were received in his department and that the outer label stated that the contents are sterile and not for reprocessing.

Manufacturer Narrative

The reported event could be confirmed with the pictures provided.The product was manufactured by stryker orthobiologics in malvern (usa).Therefore, the available complaint information was forwarded to the manufacturing site to review the related quality and manufacturing documents.The device history records (dhrs) for all medpor products packaged at millstone medical outsourcing were reviewed.The dhrs contain a sample of the labels printed for the corresponding lots.It was found that the label for eighteen lots of non-sterile products incorrectly contained symbols for sterile products.The complained device was not returned for investigation.However, images were provided that illustrate the incorrect label of the non-sterile product.On the lower part of the label a ¿sterile¿ symbol as well as symbols for ¿do not reuse¿ and ¿do not resterilize¿ are incorrectly present.Based on the investigation it can be clearly stated that the root cause of this complaint is manufacturing related and resulted from the operator millstone medical outsourcing (mmo) selecting the incorrect format during label generation; an nc was opened.A recall was conducted for the affected products.Part numbers were linked to specific label templates, correcting label specifications to reflect the correct template for the affected products and optimizing the process at mmo were implemented actions to eliminate the complaint root cause.The results from the capa effectiveness check are still pending and will be finalized on 2018-jan-17.The complaint is added to the complaint trend.Actual device not returned, but enough identification information was provided to perform a complete manufacturing/labeling review.

Event Description

It was reported by the quality officer that the non-sterile stent sizers were received in his department and that the outer label stated that the contents are sterile and not for reprocessing.

• Brand Name: PETITE NASAL DORSUM SIZER SET
• Type of Device: INSTRUMENT
• Manufacturer (Section D): STRYKER ORTHOBIOLOGICS-MALVERN; 45 great valley parkway; malvern PA 19355
• Manufacturer (Section G): STRYKER ORTHOBIOLOGICS-MALVERN; 45 great valley parkway; malvern PA 19355
• Manufacturer Contact: kelli dykstra ; boetzingerstr. 41; freiburg D-791-11 ; 76145120
• MDR Report Key: 6211845
• MDR Text Key: 63819189
• Report Number: 0008010177-2016-00307
• Device Sequence Number: 1
• Product Code: HWT
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Remedial Action: Relabeling
• 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?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 85000
• Device Lot Number: M1603003
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/06/2016
• Initial Date FDA Received: 12/28/2016
• Supplement Dates Manufacturer Received: 12/06/2016
• Supplement Dates FDA Received: 01/31/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/08/2016
• 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