MAUDE Adverse Event Report: I.T.S. GMBH STRAIGHT PLATE, 4.5MM, 13-HOLE

Model Number	21103-13
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Information (3190)
Date of Event	05/29/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history record (dhr) of this plate 21103-13 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 asked an experienced trauma surgeon for an additional independent opinion: the patient had a competitor plate implanted and broke 6 months after surgery.This breakage is caused by pseudoarthrosis, as the fracture should have consolidated after 6 months completely, which is not the case.When implanting a plate at pseudoarthrosis, the plate is not allowed to have a swinging distance.If so, the bone healing is not stimulated.Instead the fracture segments should be compressed to stimulate the bone healing.Furthermore, a spongioplastic should have be done to stimulate the bone for healing.The best choice at the initial surgery would be a intramedullary nail.
Event or Problem Description
It was reported that a straight plate, 4.5mm, 13-hole was determined to be broken postoperatively.Original implant date: (b)(6) 2019.A revision surgery was performed on (b)(6) 2019.

• Brand Name: STRAIGHT PLATE, 4.5MM, 13-HOLE
• Common Device Name: STRAIGHT PLATE, 4.5MM, 13-HOLE
• Manufacturer (Section D): I.T.S. GMBH; autal 28; lassnitzh?he, 8301 ; AU 8301
• MDR Report Key: 8669638
• Report Number: 3004369035-2019-00004
• Device Sequence Number: 11284415
• Product Code: HRS
• UDI-Device Identifier: 09120034304781
• UDI-Public: 09120034304781
• Combination Product (Y/N): N
• PMA/510(K) Number: K060156
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/05/2019

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: 21103-13
• Device Catalogue Number: 21103-13
• Device Lot Number: 147/416603
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/31/2019
• Initial Report FDA Received Date: 06/05/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention