MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA SCREWS: MPACT 01.32.6530 CANCELLOUS BONE SCREW, FLAT HEAD Ø 6,5 L 30; HIP BONE SCREW

Catalog Number	01.32.6530
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/16/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 26 july 2019: lot 1902135: (b)(4) items manufactured and released on 2-apr-2019.Expiration date: 2024-03-19.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.Another implant involved (it is unknown if the broken screw is this one or the previous listed one, the broken screw is only one).Screws: mpact 01.32.6530 cancellous bone screw, flat head ø 6,5 l 30 lot.178057 (k103721).Batch review performed on 26 july 2019: lot 178057: (b)(4) items manufactured and released on 21-dec-2017.Expiration date: 2022-11-22.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.
Event or Problem Description
While the surgeon was screwing one of the two implanted screws, the head of the screw broke and remained on the screwdriver.The threaded body remained implanted (in the correct position) in the patient.

• Brand Name: SCREWS: MPACT 01.32.6530 CANCELLOUS BONE SCREW, FLAT HEAD Ø 6,5 L 30
• Common Device Name: HIP BONE SCREW
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 8878374
• Report Number: 3005180920-2019-00675
• Device Sequence Number: 2206038
• Product Code: LPH
• UDI-Device Identifier: 07630030812392
• UDI-Public: 07630030812392
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K103721
• 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): 08/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/19/2024
• Device Catalogue Number: 01.32.6530
• Device Lot Number: 1902135
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/16/2019
• Initial Report FDA Received Date: 08/09/2019
• 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: 36 YR
• Patient Weight: 100