MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG BONE SCREWS, CROSS-PIN, SELF-TAPPING, DIAM.1.2X4MM, UPPERFACE, (5/PACKAGE); IMPLANT

Catalog Number 50-12004

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

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/18/2016

Event Type  malfunction  

Manufacturer Narrative

The device is not available for evaluation.If additional information is received it will be reported on a supplemental report.The product was discarded by the facility at their location.

Event Description

It was reported by a company representative that during a medical procedure the screw head broke off from the screw body at the top of the screw threads during torque/insertion.The head part of the screw that broke off was recovered, and the remaining part of the screw body was left in the patient bone.The procedure was completed successfully without a delay.No medical intervention and no adverse consequences were reported with this event.

Manufacturer Narrative

The reported event of a screw breakage could not be confirmed since the complained product was not returned.It was stated that blade 62-12170 was used in the reported case, which is appropriate for the usage with the complained screw.However, the complained screw was not returned for investigation.So the failure mode could not be attributed to a certain root cause.According to the related risk management file, the most likely root causes could have been: wrong pilot hole - screw interface due to wrong hole diameter/ tapped hole.Insufficient/too high bone quality.Wrong/ missing information.Reuse of single-use devices.Improper implant placement.Too much/ wrong forces between blade, screw and bone (e.G.Screw head deformation, screw breakage).Power tool usage for screw insertion (except 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 mix-up, poorly assembled/used instrument).Powered screw insertion with right angled screwdriver.Based on statistical evaluation there are no indications for any systematic design, material, or manufacturing related issue.Therefore, no corrective and/or preventive actions are deemed necessary at this time.The complaint is added to the complaint trend.

Event Description

It was reported by a company representative that during a medical procedure the screw head broke off from the screw body at the top of the screw threads during torque/insertion.The head part of the screw that broke off was recovered, and the remaining part of the screw body was left in the patient bone.The procedure was completed successfully without a delay.No medical intervention and no adverse consequences were reported with this event.

• Brand Name: BONE SCREWS, CROSS-PIN, SELF-TAPPING, DIAM.1.2X4MM, UPPERFACE, (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: gregory gohl ; boetzingerstr. 41; freiburg D-791-11 ; 76145120
• MDR Report Key: 6150587
• MDR Text Key: 62128113
• Report Number: 0008010177-2016-00286
• Device Sequence Number: 1
• Product Code: JEY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K022185
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/21/2017

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: 50-12004
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/18/2016
• Initial Date FDA Received: 12/07/2016
• Supplement Dates Manufacturer Received: 11/18/2016
• Supplement Dates FDA Received: 07/21/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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