MAUDE Adverse Event Report: I.T.S. GMBH PROXIMAL HUMERAL PLATE

Model Number	21133-4
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Information (3190)
Date of Event	06/06/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the device history record revealed no complaint regarding related anomalies.The dhr shows this lot of proximal humeral plate 4-hole as well as the locking screws were processed through normal manufacturing and inspection operations with no non-conformances or rework noted.The product lots 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.In addition, we have inspected the returned device and made a material analysis as well as a dimensional check and no deviation was detected.The plate holes were inspected with an electronic magnifier and the top of the plate holes have only slight grooves, indicating that the screws were not fully locked with the plate.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported that 6 months after a proximal humeral fracture treated with a proximal humeral plate the locking screws got loose.A revision surgery was performed at an unknown date and the plate as well as the screws were explanted and furthermore treated with an unknown device.There was no delays in surgery.

• Brand Name: PROXIMAL HUMERAL PLATE
• Common Device Name: PROXIMAL HUMERAL PLATE
• Manufacturer (Section D): I.T.S. GMBH; autal 28; lassnitzhöhe, styria 8301 ; AU 8301
• MDR Report Key: 7756143
• Report Number: 3004369035-2018-00008
• Device Sequence Number: 1280390
• 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: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/07/2018

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
• Device Lot Number: 43/0091
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/03/2018
• Initial Report FDA Received Date: 08/07/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR