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

Catalog Number	01.32.6535
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	06/18/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 12 july 2019: lot 186440: (b)(4) items manufactured and released on 18-sept-2018.Expiration date: 2023-08-21.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.Preliminary investigation performed by r&d project manager.Preliminary investigation performed on 17 july 2019.From the receive images, it is not possible to determine the root cause of the event.Images show only the labels.Another device was involved in the event.Batch review performed on 12 july 2019: screws: mpact 01.32.6535 cancellous bone screw, flat head ø 6,5 l 35 (k103721): lot 167234: (b)(4) items manufactured and released on 29-nov-2016.Expiration date: 2021-11-17.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.Visual inspection performed by r&d project manager.The head of the screw was checked: the breakage was in the proximity of the hexagonal hole.The event could be probably related to a flexion force applied during the insertion of the screw but from the received information it is not possible to determine with certainty the root cause of the event.
Event or Problem Description
One of the screw head sheered of off during the insertion into the acetabulum.No impingement of the broken screw to the liner, so it was left in place and liner implanted.It is unknown which of the 2 implanted screws is the broken one as both were opened at the same time and both are of the same length.

• Brand Name: SCREWS: MPACT CANCELLOUS BONE SCREW, FLAT HEAD Ø 6,5 L 35
• Common Device Name: HIP CANCELLOUS BONE SCREW
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 8806110
• Report Number: 3005180920-2019-00580
• Device Sequence Number: 13567363
• Product Code: LPH
• UDI-Device Identifier: 07630030812408
• UDI-Public: 07630030812408
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K103721
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/19/2019

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: 08/21/2023
• Device Catalogue Number: 01.32.6535
• Device Lot Number: 186440
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/19/2019
• Initial Report FDA Received Date: 07/19/2019
• 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: 22 YR
• Patient Weight: 45