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

Model Number 21015-08

Device Problems Accessory Incompatible (1004); Defective Component (2292)

Patient Problem No Information (3190)

Event Type  malfunction  

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 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
• Type of Device: HALLUX OSTEOTOMY PLATE, 8MM
• Manufacturer (Section D): I.T.S. GMBH; autal 28; lassnitzh[?]he, styria 8301 ; AU 8301
• Manufacturer (Section G): I.T.S. GMBH; autal 28; lassnitzh[?]he, styria 8301 ; AU 8301
• Manufacturer Contact: florian grill ; autal 28; lassnitzh[?]he, styria 8301 ; AU 8301
• MDR Report Key: 8230298
• MDR Text Key: 133342483
• Report Number: 3004369035-2016-00001
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 09120047298664
• UDI-Public: 09120047298664
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131722
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Administrator/Supervisor
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 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
• Device Operator: No Information
• Device Model Number: 21015-08
• Device Catalogue Number: 21015-08
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 01/11/2016
• Initial Date FDA Received: 01/09/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1