MAUDE Adverse Event Report: I.T.S. GMBH FLS PLATE, CURVED, 5-HOLE, LEFT

Model Number	21412-5
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Information (3190)
Date of Event	07/31/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The qc documents showed no deviations and despite several requests regarding my questions, i haven't received proper answers from the rep and the surgeon.The device history record (dhr) of this plate 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, this complaint is deemed unconfirmed.
Event or Problem Description
It was reported that a curved foot plate 5-hole broke 1/2 y + original implant date (b)(6) 2020.Plate used for mtpj arthrodesis.

• Brand Name: FLS PLATE, CURVED, 5-HOLE, LEFT
• Common Device Name: FLS PLATE, CURVED, 5-HOLE, LEFT
• Manufacturer (Section D): I.T.S. GMBH; autal 28; lassnitzhöhe, styria 8301 ; AU 8301
• MDR Report Key: 10360477
• Report Number: 3004369035-2020-00006
• Device Sequence Number: 3462936
• Product Code: HRS
• UDI-Device Identifier: 09120047299302
• UDI-Public: 09120047299302
• 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: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/04/2020

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: 21412-5
• Device Catalogue Number: 21412-5
• Device Lot Number: 26/F34558
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/31/2020
• Initial Report FDA Received Date: 08/04/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention