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

Model Number 21015-08

Device Problem Unintended System Motion (1430)

Patient Problem Non-union Bone Fracture (2369)

Event Date 12/23/2021

Event Type  Injury  

Manufacturer Narrative

A review of the device history record (dhr) revealed no complaint related anomalies.The (dhr) shows this lot of the hallux osteotomy plate was processed through the normal manufacturing and inspection operations with no non-conformances or rework noted.This order met all dimensional and visual criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.A review of the raw material device history record revealed no non-conformance.We have consulted an experienced trauma surgeon for his indepenent opinion: the x-rays show a gap in the area of the osteotomy, which can contribute to delayed bone healing.Apparently, the periosteal tissue was extensively damaged in the course of the osteotomy, as it is untypical that there are still no signs of bone healing after 1-1,5 months.It is suspected, that a too small implant size was chosen, thus led to improper anchoring of the barbs in the intramedullary canal and subsequent caused the screw passing through the plate hole.This is report 1 of 2.

Event Description

It was reported that the locking screw passed the plate hole approx.1-1,5 months post-op.

• 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: 13364790
• MDR Text Key: 284505795
• Report Number: 3004369035-2022-00001
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 09120047298664
• UDI-Public: 9120047298664
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K131722
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 21015-08
• Device Catalogue Number: 21015-08
• Device Lot Number: 00/0720-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2022
• Date Manufacturer Received: 01/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention