MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE 8MM VERSITOMIC ISI BIOSTEON TAP; TAP, BONE

Catalog Number 234-118-008

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 10/03/2017

Event Type  Injury  

Manufacturer Narrative

This record will be filed on behalf of the legal manufacturer, tag medical products.Additional information will be provided once the investigation has been completed.The device manufacture date is not known at this time.However, should it become available, it will be provided in future reports.

Event Description

It was reported that the product broke.The broken piece was not retrieved from the patient.

Manufacturer Narrative

This record will be filed on behalf of the legal manufacturer, tag medical products.Device broken, distal end is missing.Functional test could not be performed since device was broken.This device was manufactured in 2014 and is well over it's service life.According to tag medical probable root cause is missuse.The product was returned for investigation and the reported failure mode was confirmed.The failure mode will be monitored for future reoccurrence.

Event Description

It was reported that the product broke.The broken piece was not retrieved from the patient.

• Brand Name: 8MM VERSITOMIC ISI BIOSTEON TAP
• Type of Device: TAP, BONE
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• Manufacturer (Section G): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• Manufacturer Contact: ashley lower ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 6996201
• MDR Text Key: 90869613
• Report Number: 0002936485-2017-01041
• Device Sequence Number: 1
• Product Code: HWX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 234-118-008
• Device Lot Number: 14E02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/03/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/09/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other