MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA PEDICLE SCREW CROSS CONNECTOR 48-66

Catalog Number	03.56.048
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	03/29/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 23 april 2019: lot 1821808: (b)(4) items manufactured and released on 04-oct-2018.Expiration date: 2023-09-13.No anomalies found related to the issue.To date, (b)(4) items of this lot have already been sold without any other similar reported event.Visual inspection performed by r&d (b)(4): the cross connector, ref.(b)(4) lot.1821808, has a broken screw.The head of the screw and the hook, that are visible in the complaints picture, were not analyzed because we haven't received back.The cross connector has a clear breaking area and also scratches.On the bottom of the screw there is a breaking area.The root cause of the breakage is not clear identified but it seems compatible with the application of uncontrolled force or manoeuver on the screw or cross connector during the assembling.Additional information: a 100% functional control has been performed on all the pieces of the lot before the release.Furthermore, in order to check the functionality and the effectiveness of this lot, some bechwise tests have been performed.On the same ref and lot, it was possible to tighten the screw up the 10nm without any failure (the correct instrument provided into the set tighten at 5.5nm).After tightening the cross connector has been hammered and the breaking point was the hook.Even if the screw is not designed to be disassembled, in normal condition the torque to remove the screw is approximately 4nm, but, due to the punching/deformation of the screw (validated standard process) the unscrew tightening torque could be higher.In order to simulate that, a third test has been performed on the same ref and lot, after welding the screw on the bottom, it was applied a counter-clockwise torque and the screw broke approximately at 5.5nm with the same mechanism of failure.The root cause of the breakage is due to the excessive counter-clockwise torque applied on the screw in order to remove that.The attempt to remove the screw caused primarily the breakage of the screw on the bottom.This breakage, the application of the torque or both caused the cold welding of the screw.Finally the application of an additional torque, up to 5.5nm or more, cause the screw head breakage.
Event or Problem Description
When the surgeon tried to loosen the cross connector, the locking screw broke.The surgery was finished with the back up implant.Due to this event the surgery was prolonged about 10 minutes.

• Brand Name: PEDICLE SCREW CROSS CONNECTOR 48-66
• Common Device Name: PEDICLE SCREW CROSS CONNECTOR
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8548840
• Report Number: 3005180920-2019-00318
• Device Sequence Number: 1537298
• Product Code: NKB
• UDI-Device Identifier: 07630030839795
• UDI-Public: 07630030839795
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K132878
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/25/2019

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: 09/13/2023
• Device Catalogue Number: 03.56.048
• Device Lot Number: 1821808
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/29/2019
• Initial Report FDA Received Date: 04/25/2019
• 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
• Patient Age: 78 YR
• Patient Weight: 55