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

Model Number	21133-4
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Information (3190)
Date of Event	05/23/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history record (dhr) of the last three shipments of the plate 21133-4 and the resp.Screws that were send to (b)(6) 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.The proximal plate holes showed only minor deformation.Thus the locking screws were not fully engaged in the plate.Furthermore, the screws backed out due to non-union of the humeral fracture.
Event or Problem Description
It was reported that screws backed out of a proximal humeral plate, 4-hole postoperatively.Original implant date (b)(6) 2016.A revision surgery was performed on (b)(6) 2016.

• 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: 8230385
• Report Number: 3004369035-2016-00006
• Device Sequence Number: 1624511
• Product Code: HRS
• UDI-Device Identifier: 09120047297353
• UDI-Public: 09120047297353
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K051412
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/09/2019

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?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/18/2016
• Initial Report FDA Received Date: 01/09/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR
• Patient Weight: 90