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

Catalog Number 234-118-007

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 02/06/2016

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

Alleged failure: tap broke off inserter.According to tag's investigation report attached: where product has not been returned root cause is unknown the product was not returned for investigation therefore the reported failure mode was not confirmed.The failure mode will be monitored for future reoccurrence the device manufacturer date is not known.

Event Description

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

• Brand Name: 7MM VERSITOMIC ISI BIOSTEONTAP
• 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: victoria milich ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 6382849
• MDR Text Key: 69206639
• Report Number: 0002936485-2017-00262
• 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: consumer
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2017
• 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: 0000000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/06/2017
• 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
• Patient Age: 34 YR
• Patient Weight: 84