MAUDE Adverse Event Report: I.T.S. GMBH CANCELLOUS SCREW, LOCKING, D=3.0MM, L=18MM

Model Number	37302-18
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history record (dhr) of the 3.0mm locking cancellous screws and the plate 21028-4 (26/f35385) 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.With assistance of a magnifying camera, we have detected signs of wear only at the first two thread flanks, which is not sufficient for an entire locking.Low radial force, as in this case, is sufficient to cause a loosening of the screw.We recommend for entire locking at least 1/2 to 3/4 turns with the screwdriver, measured from the first contact of the thread flanks of the head to the plate hole.
Event or Problem Description
It was reported that 2 locking cancellous screws d=3.0mm got loose in the most distal hole row of a prolock radius plate.This is report is 3 of 3.

• Brand Name: CANCELLOUS SCREW, LOCKING, D=3.0MM, L=18MM
• Common Device Name: CANCELLOUS SCREW, LOCKING, D=3.0MM, L=18MM
• Manufacturer (Section D): I.T.S. GMBH; autal 28; lassnitzh[?]he, styria 8301 ; AU 8301
• MDR Report Key: 8226353
• Report Number: 3004369035-2015-00093
• Device Sequence Number: 2069973
• Product Code: HWC
• UDI-Device Identifier: 09120034301636
• UDI-Public: 09120034301636
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K033756
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare 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
• Operator of Device: Health Professional
• Device Model Number: 37302-18
• Device Catalogue Number: 37302-18
• Device Lot Number: 26/F20425
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/25/2015
• Initial Report FDA Received Date: 01/08/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention