MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MPACT CANCELLOUS BONE SCREW, FLAT HEAD Ø 6,5 L 50

Catalog Number 01.32.6550

Device Problem Bent (1059)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/02/2017

Event Type  malfunction  

Manufacturer Narrative

Additional information received on 09 june 2017 and includes: if the surgeon continued to tighten the screw, he would have broken it.The surgeon used the universal handle.Batch review performed on 26 june 2017.Lot 132489: (b)(4) items manufactured and released on 11 december 2013.Expiration date: 2018-06-30.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.Not yet received.

Event Description

When the surgeon was implanting the screw, the screw bent.The surgeon used a smaller screw to complete the surgery.There was a short delay of less than 2 minutes.The surgery was completed successfully.X-rays are not available; implant is available.

Manufacturer Narrative

On 04 july 2017 the r&d project manager performed a visual inspection of the retrieved item and commented as follows: the piece was analyzed.The screw is bent in the part closed to the screw head.It is not clear how it was happened and we can not determinate with certainty the root cause of the event, but we can assume that it is due to an erroneous use during surgery: in order to correct the direction of insertion, the surgeon would have applied a force in flexion to provide the bending of the acetabular screw.

• Brand Name: MPACT CANCELLOUS BONE SCREW, FLAT HEAD Ø 6,5 L 50
• Type of Device: CANCELLOUS BONE SCREW
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 6680312
• MDR Text Key: 79037856
• Report Number: 3005180920-2017-00350
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132879
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2018
• Device Catalogue Number: 01.32.6550
• Device Lot Number: 132489
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/02/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/11/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other