MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MPACT CANCELLOUS BONE SCREW, FLAT HEAD Ø 6,5 L 40

Catalog Number	01.32.6540
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	06/20/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
On 14 july 2017 the (b)(4) performed a preliminary investigation based on the available image and commented as follows: the image was checked.The screw appeared to be broken in the head.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.On 17 july 2017 the (b)(4) performed a clinical evaluation and commented as follows: screw fracture occurred during surgery.On the basis of the information provided it is not possible to determine the cause of this event.Normally, screw heads can be sheared off by exerting a flexion moment during tightening.Strength is limited by the dimensional constraints.After the removal of broken pieces from the surgical field, no negative consequences for the patient is expected.Batch review performed on 19 july 2017.Lot 168800: (b)(4) items manufactured and released on 15 february 2017.Expiration date: 2022-02-02.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
When the surgeon was implanting the screw, the head of the screw broke off.The surgeon recovered the screw head.The shaft of the screw remains implanted into the patient.There was approximately a 5 minute delay in surgery.The surgery was completed successfully.X-rays are available.Explants are not available.

• Brand Name: MPACT CANCELLOUS BONE SCREW, FLAT HEAD Ø 6,5 L 40
• Common Device Name: CANCELLOUS BONE SCREW
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 6727733
• Report Number: 3005180920-2017-00391
• Device Sequence Number: 13634661
• 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
• Report Date (Section B): 07/20/2017

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: 02/02/2022
• Device Catalogue Number: 01.32.6540
• Device Lot Number: 168800
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/20/2017
• Initial Report FDA Received Date: 07/20/2017
• 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