MAUDE Adverse Event Report: I.T.S. GMBH HUMERAL HEAD PLATE, WIDE, 3-HOLE

Model Number	21131-3
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Information (3190)
Date of Event	02/03/2014
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history record (dhr) of this plate 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: the implant breakage is related to a delayed fracture healing / pseudoarthrosis (4 months).
Event or Problem Description
It was reported that a humeral head plate, wide, 3-hole was determined to be broken postoperatively.Original implant date (b)(6) 2013.A revision surgery was performed on (b)(6) 2014.

• Brand Name: HUMERAL HEAD PLATE, WIDE, 3-HOLE
• Common Device Name: HUMERAL HEAD PLATE, WIDE, 3-HOLE
• Manufacturer (Section D): I.T.S. GMBH; autal 28; lassnitzh[?]he, styria 8301 ; AU 8301
• MDR Report Key: 8225547
• Report Number: 3004369035-2014-00001
• Device Sequence Number: 11280028
• Product Code: HRS
• UDI-Device Identifier: 09120034302992
• UDI-Public: 09120034302992
• 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: 2013
• Device Explanted 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: 21131-3
• Device Catalogue Number: 21131-3
• Device Lot Number: 26/F30457
• Was Device Available for Evaluation?: Yes
• 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: 70 YR
• Patient Weight: 70