MAUDE Adverse Event Report: I.T.S. GMBH STRAIGHT PLATE, 3.5MM, 8-HOLE

Model Number	21102-8
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Information (3190)
Date of Event	10/23/2014
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history record (dhr) of this plate 21102-8 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: dr.(b)(6): the plate broke as the fracture was not reduced properly and a gap is visible.Furthermore, the third distal screw is within the fracture zone.This led to a pseudoarthrosis and subsequent to a fatigue fracture of the implant.
Event or Problem Description
It was reported that a straight plate, 3.5mm, 8-hole was determined to be broken postoperatively.Original implant date (b)(6) 2014.A revision surgery was performed on (b)(6) 2014.

• Brand Name: STRAIGHT PLATE, 3.5MM, 8-HOLE
• Common Device Name: STRAIGHT PLATE, 3.5MM, 8-HOLE
• Manufacturer (Section D): I.T.S. GMBH; autal 28; lassnitzh[?]he, styria 8301 ; AU 8301
• MDR Report Key: 8225703
• Report Number: 3004369035-2014-00007
• Device Sequence Number: 1745663
• Product Code: HRS
• UDI-Device Identifier: 09120034304736
• UDI-Public: 09120034304736
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K060156
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• 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: 21102-8
• Device Catalogue Number: 21102-8
• Device Lot Number: 147/13020B
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/02/2014
• Initial Report FDA Received Date: 01/08/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 25 YR
• Patient Weight: 55