MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG BONE SCREWS, CROSS-PIN, SELF-TAPPING, DIAM.1.2X5MM, UPPERFACE, (5/PACKAGE); IMPLANT

Catalog Number 50-12005

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

Patient Problem Foreign Body In Patient (2687)

Event Date 02/02/2018

Event Type  malfunction  

Manufacturer Narrative

Please note that the actual quantity of screws affected was three.The devices are not available for evaluation.If additional information is received it will be reported on a supplemental report.Fractured portion of screw was discarded at the facility.

Event Description

During a procedure, 3 screw heads broke off from the body of the screw.The body of the screw is still implanted in the patient, and the heads were discarded.No adverse consequences nor medical intervention was reported.

Event Description

During a procedure, 3 screw heads broke off from the body of the screw.The body of the screw is still implanted in the patient, and the heads were discarded.No adverse consequences nor medical intervention was reported.

Manufacturer Narrative

Confirmation of the reported event (intraoperative screw breakages) cannot be confirmed since the devices were not returned.Further information was requested regarding the reported case.The sales representative has mentioned through e-mail that they have used blade 62-12170 and drill 60-09504 during surgery.The used blade (62-12170) is designed to be used with 1.2 mm or 1.7 mm screws and therefore is appropriate to be used with the affected screws.Unfortunately the surgeon has used a drill (60-09504) that is designed and meant to be used for screws with a maximum length of up to 4 mm.In the related brochure, leibinger universal 2 (9410-400-184, 2011), it is shown that the drill is for screw lengths of up 4mm (fig.1).Thus the drill was inappropriate to be used with the screws in question.In the event description, it was also stated that the sales representative has noticed that the surgeon was over tightening the screws during the procedure.In sum, because the surgeon had drilled a too short hole the screws were inserted down to the bottom of the hole.When the surgeon further inserted the implant, the screws were overtightened that contributed to the reported screw breakages.Therefore the root cause of the intraoperative screw breakages can be attributed to an off label use of the above mentioned drill (60-09504).Based on statistical evaluation there are no indications for any systematic design, material or manufacturing related issue.

• Brand Name: BONE SCREWS, CROSS-PIN, SELF-TAPPING, DIAM.1.2X5MM, UPPERFACE, (5/PACKAGE)
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11
• MDR Report Key: 7288365
• MDR Text Key: 101005341
• Report Number: 0008010177-2018-00022
• Device Sequence Number: 1
• Product Code: JEY
• Combination Product (y/n): N
• PMA/PMN Number: K022185
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 05/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 50-12005
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/02/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1