MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE 10MM VERSITOMIC ISI BIOSTEON TAP; TAP, BONE

Model Number	C
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/07/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the device broke and was unable to be removed from the patient.
Additional Manufacturer Narrative
Additional information will be provided once the investigation has been completed.The device manufacturer date is not known at this time.However, should it become available it will be provided in future reports.Filing on behalf of the legal manufacturer tag medical.
Event or Problem Description
It was reported that the device broke and was unable to be removed from the patient.
Additional Manufacturer Narrative
The device was not received for evaluation at stryker endoscopy.The device was received at tag medical for evaluation.Based on the tag investigation report attached, the reported failure ¿[biosteon isi tap broke off in bone tunnel while tapping.The break occurred at the intesection of the tap threads and the shaft.Unable to remove, was left in patient acting as interference screw.]¿ was not confirmed.According to tag: "since the device was lost during shipment from the customer to tag, the device couldn't be examined.Based on the complaint description, it appears that the device got broken in the welding point between the shaft and the screw tip.According to the ifu #ifu118st, the bending angle shouldn't be smaller than 28 degrees, and the anatomic conditions of the patient should require a flexible portion smaller than 25mm.The complaint description does not elaborate on the event which caused the device to break.It is possible that the device wasn't used as intended, causing the device brakeage.Also, the device service life is only two years.Since the majority of #lot18p01 was sent to the customer on the end of 2018, it is likely that the device was overused and over worn.Therefore, it can be concluded that the device was misused." the reported failure mode will be monitored for future reoccurrence.Manufacture date is not known.H3 other text : 81.

• Brand Name: 10MM VERSITOMIC ISI BIOSTEON TAP
• Common Device Name: 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: andrea zenere ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 14754620
• Report Number: 0002936485-2022-00355
• Device Sequence Number: 20365609
• Product Code: HWX
• UDI-Device Identifier: 10810190016289
• UDI-Public: 10810190016289
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: C
• Device Catalogue Number: 234-118-010
• Device Lot Number: 18P01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/07/2022
• Supplement Date Received by Manufacturer: 06/07/2022
• Initial Report FDA Received Date: 06/21/2022
• Supplement Report FDA Received Date: 09/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 19 YR
• Patient Sex: Male