MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE 7MM VERSITOMIC ISI BIOSTEON TAP; TAP, BONE

Catalog Number 234-118-007

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 07/31/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that a portion of the device broke and remained inside the patient.

Manufacturer Narrative

This record will be filed on behalf of the legal manufacturer, tag medical products.The device manufacture date is not known.Alleged failure: tap broke off.According to tag: probable root cause: too much force applied on the device-wrong use.The product was not returned for investigation therefore the reported failure mode was not confirmed.The failure mode will be monitored for future reoccurrence.Gtin: per the legal manufacturer tag medical, the gtin was not in use at the time of manufacturing.

Event Description

It was reported that a portion of the device broke and remained inside the patient.

• Brand Name: 7MM 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: valerie estrada ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 6829335
• MDR Text Key: 83936801
• Report Number: 0002936485-2017-00825
• 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: 03/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 234-118-007
• Device Lot Number: 14E01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/31/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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