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

Model Number	37592-65
Medical Device Problem Code	Missing Value Reason (3192)
Health Effect - Clinical Code	Missing Value Reason (3192)
Date of Event	04/21/2017
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: CANCELLOUS LOCKING SCREW
• Manufacturer (Section D): I.T.S. GMBH; autal 28; lassnitzhöhe, styria 8301 ; AU 8301
• MDR Report Key: 6575103
• Report Number: 3004369035-2017-00001
• Device Sequence Number: 253594
• Product Code: HWC
• UDI-Device Identifier: 09120034306181
• UDI-Public: 09120034306181
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K063166
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Remedial Action: Relabeling
• Type of Report: Initial
• Report Date (Section B): 04/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 37592-65
• Device Catalogue Number: 37592-65
• Device Lot Number: 18/772125
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/20/2017
• Initial Report FDA Received Date: 05/18/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other