MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MUST MINI SET SCREW; MINI POSTERIOR CERVICAL SET SCREW

Catalog Number	03.75.900
Medical Device Problem Code	Device Issue (2379)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	01/04/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 30 january 2018 lot 1720835: (b)(4) items manufactured and released on 28 sept 2017.Expiration date: 2022-09-17 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.On 01 february 2018 r&d spine provided the following info: i have discussed the events with surgeon.We were able to replicate the failure of the reduction device reported after three attempts.He had to apply relay a lot of force in order to create the interface between the tulip and the reduction device to fail.This is very uncommon in the cervical spine.Concerning the cross-threading reported the problem is most likely caused by a too weak set screw thread start.He strongly press the set screw against the tulip before the start to turn the driver.By doing this he slightly can deform the thread start which cause the cross threading.
Event or Problem Description
During a posterior cervical fusion of c2-c5 the set screw sheared apart.The set screw cross threaded on the screw tulip head.Metal sheared off of the set screw while tightening it in place.The surgeon removed the set screw and irrigated the incision site.The surgeon used a secondary set screw to complete the surgery.There was a 2 minute delay in the case.The surgery was completed successfully.

• Brand Name: MUST MINI SET SCREW
• Common Device Name: MINI POSTERIOR CERVICAL SET SCREW
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 7237256
• Report Number: 3005180920-2018-00016
• Device Sequence Number: 11040358
• Product Code: NKG
• UDI-Device Identifier: 07630030865657
• UDI-Public: 07630030865657
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K171369
• 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): 02/02/2018

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: 09/17/2022
• Device Catalogue Number: 03.75.900
• Device Lot Number: 1720835
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/04/2018
• Initial Report FDA Received Date: 02/02/2018
• 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
• Patient Age: 65 YR