MAUDE Adverse Event Report: I.T.S. GMBH STRAIGHT PLATE, 4.5MM, 12-HOLE

Model Number	21103-12
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Post Operative Wound Infection (2446)
Date of Event	04/05/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history record (dhr) of the last three shipments to our distributor of the plate (b)(4) were inspected and showed no deviations as not lot number was provided.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 provided x-ray shows a transverse fracture with an infect-pseudoarthrosis and signs of non-union.There is a big comminuted zone with no medial support/buttress and thus the fracture compressed for about 30-40mm after plate breakage.If plating this kind of fracture, a second ventral aligned plate has to be used a neutralization plate.But, the preferred procedure for this kind of transverse fracture is intramedullary nailing in combination with cancellous bone graft.
Event or Problem Description
It was reported that a straight plate, 4.5mm, 12-hole was determined to be broken postoperatively.Original implant date (b)(6) 2019.A revision surgery was performed on an unknown date.

• Brand Name: STRAIGHT PLATE, 4.5MM, 12-HOLE
• Common Device Name: STRAIGHT PLATE, 4.5MM, 12-HOLE
• Manufacturer (Section D): I.T.S. GMBH; autal 28; lassnitzh?he, 8301 ; AU 8301
• MDR Report Key: 8756578
• Report Number: 3004369035-2019-00005
• Device Sequence Number: 1488899
• Product Code: HRS
• UDI-Device Identifier: 09120034304774
• UDI-Public: 09120034304774
• Combination Product (Y/N): N
• PMA/510(K) Number: K060156
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/19/2019

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: 21103-12
• Device Catalogue Number: 21103-12
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/12/2019
• Initial Report FDA Received Date: 07/03/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Weight: 59