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	Material Fragmentation (1261)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/28/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 27 march 2019: lot 187780: (b)(4) items manufactured and released on 05-nov-2018.Expiration date: 2023-10-22.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.Preliminary investigation performed by r&d (b)(4).The cancellous bone screw broke during the insertion: the root cause of the event cannot be determined with certainty; a possible cause can be related to an incorrect pre-drilling performed with drill bits or a high flexion provided to the screw that led to the breakage of the screw head.In addition, as reported by the surgeon, the patient had very hard bone and a possible cause is that the surgeon may have not drilled deep enough prior to implant the screw.
Event or Problem Description
During the primary hip surgery and while implanting the 35mm impact dome screw, the head of the screw broke off.The surgeon stated the patient had very hard bone and that he may have not drilled deep enough prior to implanting the screw.The surgeon chose to leave the broken screw in place and there was no interference between the screw and the liner.

• 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, switzerland 6874 ; SZ 6874
• MDR Report Key: 8464668
• Report Number: 3005180920-2019-00212
• Device Sequence Number: 13913105
• Product Code: LPH
• UDI-Device Identifier: 07630030812408
• UDI-Public: 07630030812408
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• 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): 03/29/2019

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: 10/22/2023
• Device Catalogue Number: 01.32.6535
• Device Lot Number: 187780
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2019
• Initial Report FDA Received Date: 03/29/2019
• 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