MAUDE Adverse Event Report: I.T.S. GMBH CANCELLOUS SCREW, LOCKING, D=4.2MM, L=28MM, SH

Model Number	37422-28-N
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Information (3190)
Date of Event	09/05/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history record (dhr) of the 37422-28-n screw of the last three shipments to the distributor 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 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.Device was used for distal tibia fracture treatment.
Event or Problem Description
It was reported that a locking cancellous screw unthreaded intraoperatively- original implant date (b)(6) 2019.

• Brand Name: CANCELLOUS SCREW, LOCKING, D=4.2MM, L=28MM, SH
• Common Device Name: CANCELLOUS SCREW, LOCKING, D=4.2MM, L=28MM, SH
• Manufacturer (Section D): I.T.S. GMBH; autal 28; lassnitzh?he, 8301 ; AU 8301
• MDR Report Key: 9102575
• Report Number: 3004369035-2019-00012
• Device Sequence Number: 2112979
• Product Code: HWC
• UDI-Device Identifier: 09120047295526
• UDI-Public: 09120047295526
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K052011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/23/2019

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: 37422-28-N
• Device Catalogue Number: 37422-28-N
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/20/2019
• Initial Report FDA Received Date: 09/23/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention