MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG BONE SCREWS, CROSS-PIN, DIAM.2.0X14MM, (5/PACKAGE); IMPLANT

Catalog Number 50-20414

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/17/2016

Event Type  malfunction  

Manufacturer Narrative

The device has not yet been received at the manufacturer for testing.An evaluation will be conducted upon receipt of the device, and a follow-up report will be submitted after the quality investigation is complete.

Event Description

It was reported that during a procedure, the head of a screw broke off after the screw had already been inserted 8-9mm.The plate was then removed and the piece of the broken screw was removed using tweezers.Then the drilling was reviewed, and another screw was inserted without any problem.Ifu guidelines were being followed.There were no associated adverse consequences.

Manufacturer Narrative

Because the complained screw was not returned, the reported event cannot be confirmed and it was not possible to determine its root cause within this investigation.A review of the risk management file, revealed the following possible root causes: - wrong pilot hole - screw interface due to wrong hole diameter/ tapped hole - incorrectly selected/ assembled implant/ instrument - insufficient/too high bone quality - wrong/ missing information - reuse of single-use devices - implant/instrument mix-up - wrong/ missing functionality check - improper implant placement (e.G.Arch bar, screw.) - too much/ wrong forces between blade, screw and bone (e.G.Screw head deformation, screw breakage) - power tool usage for screw insertion (not qdm) - too much/ wrong compression/ torsional/ axial forces - wrong rotational speed, unintended loads - bone quality resulting in high torque - improper blade disengaging - collision with other implant or instrument - predrilled hole not deep enough (e.G.Wrong choice of instrument/implant, system mixup, poorly assembled/used instrument) - powered screw insertion with right angled screwdriver.Based on the statistical evaluation there is no indication for any systematic design, material or manufacturing related issue.The complaint is added to the complaint trend.Return was cancelled as the device was unable to be returned.

Event Description

It was reported that during a procedure, the head of a screw broke off after the screw had already been inserted 8-9mm.The plate was then removed and the piece of the broken screw was removed using tweezers.Then the drilling was reviewed, and another screw was inserted without any problem.Ifu guidelines were being followed.There were no associated adverse consequences.

• Brand Name: BONE SCREWS, CROSS-PIN, DIAM.2.0X14MM, (5/PACKAGE)
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11
• Manufacturer (Section G): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11
• Manufacturer Contact: kelli dykstra ; boetzingerstr. 41; freiburg D-791-11 ; 76145120
• MDR Report Key: 5797864
• MDR Text Key: 49666314
• Report Number: 0008010177-2016-00150
• Device Sequence Number: 1
• Product Code: JEY
• Combination Product (y/n): N
• Reporter Country Code: AR
• PMA/PMN Number: K022185
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/09/2017

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
• Device Operator: Health Professional
• Device Catalogue Number: 50-20414
• Device Lot Number: 1000122862
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/21/2016
• Initial Date FDA Received: 07/15/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/09/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/13/2014
• 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