MAUDE Adverse Event Report: I.T.S. GMBH RETAINING SCREW, PROXIMAL HUMERAL PLATE

Model Number	118005-15
Medical Device Problem Code	Accessory Incompatible (1004)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
I.T.S.Gmbh received a customer complaint regarding the issue that the insertion guide of the proximal humeral plate (art.No.118005a) could not be mounted onto the appropriate implant (art.No.21133-xx) with the retaining screw (art.No.118005-15).This issue is caused by the selected dimensional tolerance in first series production.As a result, the threaded portion of the retaining screw has not or just partially engaged a few decimillimeter in the thread pitch of the plate - thus ensured no rigid mounting.The non-conformity can cause an increase in surgery time.There are no further risks for the patient.The retaining screw with the non-suitable dimensional tolerance does not affect the mechanical or functional properties of the implant.The retaining screw (art.No.118005-15) was replaced by a new retaining screw and has a modified dimensional tolerance.
Event or Problem Description
It was reported that the jig cannot be mounted on the plate with the retaining screw.This incident didn't happen during surgery.

• Brand Name: RETAINING SCREW, PROXIMAL HUMERAL PLATE
• Common Device Name: RETAINING SCREW, PROXIMAL HUMERAL PLATE
• Manufacturer (Section D): I.T.S. GMBH; autal 28; lassnitzh[?]he, styria 8301 ; AU 8301
• MDR Report Key: 8226172
• Report Number: 3004369035-2015-00008
• Device Sequence Number: 11234486
• Product Code: FZX
• UDI-Device Identifier: 09120047306123
• UDI-Public: 09120047306123
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K051412
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Remedial Action: Replace
• 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: 118005-15
• Device Catalogue Number: 118005-15
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/09/2015
• Initial Report FDA Received Date: 01/08/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention