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

Catalog Number 234-118-008

Device Problems Break (1069); Detachment Of Device Component (1104)

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

Event Date 04/02/2018

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 the tap broke off distally into the patient.

Manufacturer Narrative

This device was not received for evaluation at stryker endoscopy.This device was received at oem (tag medical) for evaluation.Based on the tag medical's service record attached, the reported failure ¿[tap broke off distally into femur]¿ was confirmed.The device is broken, and none of the functional or dimensional test could be performed.It was noticed that the device was used with a radius of less than 25 mm.In the ifu118st it says there are limitations for the use of this device.It states "bending angles must be smaller than 28 degrees and that the device should not be bent with a radius of less than 25mm.As no detailed explanation was forwarded as to the conditions of the use of device we conclude that he device was used over it's limitations as described in the ifu.The failure mode will be monitored for future reoccurrence.

Event Description

It was reported the tap broke off distally into 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: chester rebugio ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 7478723
• MDR Text Key: 107066912
• Report Number: 0002936485-2018-00385
• Device Sequence Number: 1
• Product Code: HWX
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 10/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2018
• 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: 15A01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/03/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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 Weight: 200