MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CANCELLOUS BONE SCREW FLAT HEAD Ø 6,5 L 35

Catalog Number	01.26.65.35
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	08/20/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 18 september 2018.Lot 153636: (b)(4) items manufactured and released on 23 september 2015.Expiration date: 2020-06-30 no anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Clinical evaluation performed on 18 september 2018 by medical affairs director: the clinical evaluation cannot find out what the reason for this problem could have been.No clinical cause seems to be possible.Thread dimensions and hole diameter are standardized.The diameter of the drill could not be verified after the operation, but there is no reason to suspect an error.Metrological analysis performed by quality control manager on 13 september 2018.The dimensional control, has not identified any anomaly or production defect.The device are conforming to the specifications of project.Visual inspection performed on 18 september 2018 by r and d product manager: after dimensional control, no dimensional defects emerge on the screws 01.26.65.35 cancellous bone screw flat head d.6.5 mm l35 mm lot.153636.The cause of the failure of the implant positioning in the related seat is not related to the implant.
Event or Problem Description
During an amis surgery the surgeon was not be able to put a second screw to fix a versafit cup cc trio.The bone was sclerotic.He tried to fix it for 15 min but he was not able to screw and enter in the bone, even if he had drilled the hole and had used the instrument guide according the procedures.He decided to leave one screw only as he commented it was enough fix the cup.

• Brand Name: CANCELLOUS BONE SCREW FLAT HEAD Ø 6,5 L 35
• Common Device Name: CANCELLOUS BONE SCREW
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 7888908
• Report Number: 3005180920-2018-00697
• Device Sequence Number: 1928060
• Product Code: LZO
• UDI-Device Identifier: 07630030808357
• UDI-Public: 07630030808357
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K103352
• 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): 09/19/2018

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 Expiration Date: 06/30/2020
• Device Catalogue Number: 01.26.65.35
• Device Lot Number: 153636
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/20/2018
• Initial Report FDA Received Date: 09/19/2018
• 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
• Patient Age: 81 YR
• Patient Weight: 67