MAUDE Adverse Event Report: I.T.S. GMBH TORQUE-SHANK, T7X80 CANNULATED, AO CONNECTOR

Model Number	54098-80
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Information (3190)
Date of Event	12/05/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history record (dhr) of the last three shipments of the 61152-100 drill were inspected and showed no deviations.The quality forms met all dimensional and visual criteria at the time of release with no issues documented during the manufacturing that would contribute to this complaint condition.A review of the raw material device history record revealed no deviation.The material was determined to be conforming and was used as is per product development approval.As a result of the above and the fact that no device was returned for evaluation and further information is missing, this complaint is deemed unconfirmed.
Event or Problem Description
It was reported that a cannulated drill bit broke during surgery.
Additional Manufacturer Narrative
The device history record (dhr) of the article 54098-80 was inspected and showed no deviations.The quality forms met all dimensional and visual criteria at the time of release with no issues documented during the manufacturing that would contribute to this complaint condition.A review of the raw material device history record revealed no deviation.The material was determined to be conforming and was used as is per product development approval.As a result of the above and the fact that no device was returned for evaluation and further information is missing, this complaint is deemed unconfirmed.
Event or Problem Description
It was reported that a screwdriver shank broke intraoperatively.

• Brand Name: TORQUE-SHANK, T7X80 CANNULATED, AO CONNECTOR
• Common Device Name: TORQUE-SHANK, T7X80 CANNULATED, AO CONNECTOR
• Manufacturer (Section D): I.T.S. GMBH; autal 28; lassnitzh?he, styria 8301 ; AU 8301
• MDR Report Key: 9556852
• Report Number: 3004369035-2019-00017
• Device Sequence Number: 3389082
• Product Code: HXX
• UDI-Device Identifier: 09120047301128
• UDI-Public: 09120047301128
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K131722
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/07/2020

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?: No
• Operator of Device: Health Professional
• Device Model Number: 54098-80
• Device Catalogue Number: 54098-80
• Device Lot Number: 27/0214
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/31/2019
• Supplement Date Received by Manufacturer: 12/31/2019
• Initial Report FDA Received Date: 01/07/2020
• Supplement Report FDA Received Date: 01/14/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other