MAUDE Adverse Event Report: I.T.S. GMBH CANCELLOUS SCREW, LOCKING, D=5.9MM, L=65MM; CANCELLOUS LOCKING SCREW

Model Number 37592-65

Device Problem Missing Value Reason (3192)

Patient Problem Missing Value Reason (3192)

Event Date 04/21/2017

Event Type  malfunction  

Manufacturer Narrative

We received the feedback from our distributor, that the label of two screws with the art.No 37592-65 and the lot no.18/772125 differs from the content.The investigation showed that five labels got reprinted on 3rd of november 2016.After checking the data in the erp system, three facilities resp.Distributors have received these implants.There is no risk for any patient or surgeon or third party.The non-conformance gets identified at refilling the non-sterile screws in the screw caddy, which happens prior to the cleaning and disinfection process and so prior to the use in the o.R.

Event Description

We received the feedback from our distributor, that the data on the label differs from the content of the non-sterile implant packaging.The information on the label showed a cancellous locking screw 5.9mm and the content was a stabilization locking screw 2.4mm.The issue was identified at goods-in inspection from our distributor, so there was no risk associated with a patient, surgeon or third party.The screws get delivered non-sterile to the facility, so the non-conformance gets identified latest at refilling the sterilization tray prior to the cleaning and disinfection process and prior to any surgery.

• Brand Name: CANCELLOUS SCREW, LOCKING, D=5.9MM, L=65MM
• Type of Device: CANCELLOUS LOCKING SCREW
• Manufacturer (Section D): I.T.S. GMBH; autal 28; lassnitzhöhe, styria 8301 ; AU 8301
• Manufacturer (Section G): I.T.S. GMBH; autal 28; lassnitzhöhe, styria 8301 ; AU 8301
• Manufacturer Contact: florian grill ; autal 28; lassnitzhöhe, styria 8301 ; AU 8301 ; 3316211214
• MDR Report Key: 6575103
• MDR Text Key: 75521972
• Report Number: 3004369035-2017-00001
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 09120034306181
• UDI-Public: 09120034306181
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K063166
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: distributor
• Reporter Occupation: Other
• Remedial Action: Relabeling
• Type of Report: Initial
• Report Date: 04/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 37592-65
• Device Catalogue Number: 37592-65
• Device Lot Number: 18/772125
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/03/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other