MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MPACT BONE SCREW

Catalog Number	01.32.6540
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	11/22/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On (b)(6) 2017 the r&d project manager checked the pictures received commenting as following: the bayonet drills were broken, the cause of the breaking might be an excess of flexion during their use.Batch review performed on (b)(6) 2017.Lot 172444: (b)(4) items manufactured and released on (b)(6) 2017.Expiration date:08/07/2022.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.Lots of the broken instruments are unknown.
Event or Problem Description
During surgery when the surgeon was drilling for a screw the drill bit broke.The surgeon used a secondary drill bit.The second drill bit also broke.All fragments from both bits were recovered.The surgeon used a tertiary drill bit to complete the surgery.Then, while implanting the screw, the screw hub broke off.The threads remain in the patient.The surgeon used a secondary screw to secure the cup.The surgery was completed successfully.
Additional Manufacturer Narrative
Preliminary investigation performed on (b)(6) 2018 by r&d product manager on (b)(6) 2018.Only the screw is shown in the picture.It is not clear how it was happened and we can not determinate with certainty the root cause of the event, but it is possible that, in order to correct the direction of insertion, the surgeon would have applied a force in flexion to provide the breakage of the screw.

• Brand Name: MPACT BONE SCREW
• Common Device Name: BONE SCREW
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 7142940
• Report Number: 3005180920-2017-00773
• Device Sequence Number: 927829
• Product Code: LPH
• UDI-Device Identifier: 07630030812415
• UDI-Public: 07630030812415
• 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
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/21/2018

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: 08/17/2022
• Device Catalogue Number: 01.32.6540
• Device Lot Number: 172444
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/22/2017
• Supplement Date Received by Manufacturer: 12/22/2017
• Initial Report FDA Received Date: 12/22/2017
• Supplement Report FDA Received Date: 03/21/2018
• 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