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 04/26/2018

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 and remained inside of the patient.

Manufacturer Narrative

The product was not returned for investigation therefore the reported failure mode was not confirmed.The failure mode will be monitored for future reoccurrence.Alleged failure: tap broke off.Probable root cause: over service life and to much force.The device manufacturer date is not known.

Event Description

It was reported that the product broke and remained inside of 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
• MDR Report Key: 7532205
• MDR Text Key: 108852888
• Report Number: 0002936485-2018-00445
• Device Sequence Number: 1
• Product Code: HWX
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 11/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2018
• 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: 14E02
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 18 YR
• Patient Weight: 73