MAUDE Adverse Event Report: I.T.S. GMBH PROXIMAL HUMERAL PLATE, 4-HOLE

Model Number	21133-4
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history record (dhr) of the last three shipments to (b)(6) of the plate 21133-4 and the resp.Screws 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.We have consulted an experienced trauma surgeon for his independent opinion: (b)(6): the x-ray shows a subcapital fracture that was not reduced in good way.This led to a pseudoarthrosis and subsequent to a fatigue fracture of the implant.Furthermore, the plate is not indicated for subcapital humeral fractures.
Event or Problem Description
It was reported that screws backed out of a proximal humeral plate, 4-hole postoperatively.Original implant date in (b)(6) 2014.A revision surgery was performed on an unknown date.

• Brand Name: PROXIMAL HUMERAL PLATE, 4-HOLE
• Common Device Name: PROXIMAL HUMERAL PLATE, 4-HOLE
• Manufacturer (Section D): I.T.S. GMBH; autal 28; lassnitzh[?]he, styria 8301 ; AU 8301
• MDR Report Key: 8225699
• Report Number: 3004369035-2014-00006
• Device Sequence Number: 11269313
• Product Code: HRS
• UDI-Device Identifier: 09120047297353
• UDI-Public: 09120047297353
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K051412
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/08/2019

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: 21133-4
• Device Catalogue Number: 21133-4
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/08/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 41 YR
• Patient Weight: 65