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

Model Number	21015-08
Medical Device Problem Code	Unintended System Motion (1430)
Health Effect - Clinical Code	Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	12/23/2021
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 3004369035-2022-00001
• Device Sequence Number: 5059070
• Product Code: HRS
• UDI-Device Identifier: 09120047298664
• UDI-Public: 9120047298664
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K131722
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/27/2022

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: 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/17/2022
• Initial Report FDA Received Date: 01/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown