MAUDE Adverse Event Report: I.T.S. GMBH HALLUX OSTEOTOMY PLATE, 8MM

Model Number	21015-08
Medical Device Problem Codes	Accessory Incompatible (1004); Defective Component (2292)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history record (dhr) of hallux plates were inspected and showed deviations in distal measurement.The field of tolerance of the nominal size is 8.00mm and 7.90.The actual size of the affected lots was between 8.11 and 8,16.All other measurements including the hole clearance are within the field of tolerance.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, the affected plates got exchanged and the incident was filed in addition under the capa number (b)(4).
Event or Problem Description
It was reported that the hallux osteotomy plate couldn't be mounted on the insertion guide.The incident didn't happen during surgery.

• Brand Name: HALLUX OSTEOTOMY PLATE, 8MM
• Common Device Name: HALLUX OSTEOTOMY PLATE, 8MM
• Manufacturer (Section D): I.T.S. GMBH; autal 28; lassnitzh[?]he, styria 8301 ; AU 8301
• MDR Report Key: 8230298
• Report Number: 3004369035-2016-00001
• Device Sequence Number: 11000512
• Product Code: HRS
• UDI-Device Identifier: 09120047298664
• UDI-Public: 09120047298664
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K131722
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 01/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: 21015-08
• Device Catalogue Number: 21015-08
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/11/2016
• Initial Report FDA Received Date: 01/09/2019
• Patient Sequence Number: 1