MAUDE Adverse Event Report: I.T.S. GMBH STABILIZATION SCREW, D=2.4MM, L=22MM, RH

Model Number	37241-22
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Information (3190)
Date of Event	12/03/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
We have inspected the qc documents of the affected product and the quality inspection forms as well as the material certificates showed no deviations and complies with the specifications.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.Put it in on power with drill with a.8 torque on.However the surgeon left proud and "wanted to feel it lock into the plate".Proceeded to lock by hand however it kept spinning.He asked if it looked right.The screw had went through the plate.He was not using much force.Was able to back the screw out by hand through the plate as well with no problem.The threads on screw looked fine.Proceeded with a medium plate and didn't use that screw.This report is 2/2.
Event or Problem Description
It was reported that a 2.4mm locking screw went through a plate hole of a distal radius plate.
Additional Manufacturer Narrative
This is a follow-up report to 3004369035-2019-00161.On 27th of january we received the affected products back.The measuring's results show a highly deformed plate hole as well as an oval deformed screw head.The measured reference plate hole (right next to it) is within the specifications (see final report).Violation regarding the maximum number of re-screwing cannot be excluded.

• Brand Name: STABILIZATION SCREW, D=2.4MM, L=22MM, RH
• Common Device Name: STABILIZATION SCREW, D=2.4MM, L=22MM, RH
• Manufacturer (Section D): I.T.S. GMBH; autal 28; lassnitzh[?]he, styria 8301 ; AU 8301
• MDR Report Key: 9450378
• Report Number: 3004369035-2019-00161
• Device Sequence Number: 14225812
• Product Code: HWC
• UDI-Device Identifier: 09120047294758
• UDI-Public: 09120047294758
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K033756
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2019

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: 37241-22
• Device Catalogue Number: 37241-22
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/03/2019
• Supplement Date Received by Manufacturer: 12/03/2019
• Initial Report FDA Received Date: 12/11/2019
• Supplement Report FDA Received Date: 01/28/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention