MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG BONE SCREW, CROSS-PIN, DIAM.2.0X6MM, (1/PACKAGE); IMPLANT

Catalog Number	50-20406E
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/18/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is not available for evaluation.If additional information is received it will be reported on a supplemental report.Device still in patient.
Event or Problem Description
It was reported that screw head had sheared off post-operatively.No medical intervention is required.
Additional Manufacturer Narrative
Even if the device was not returned, an image has been provided in trackwise that confirms the reported event ¿sheared off screw head¿.The device could not be returned.It was confirmed that screwdriver blade 62-20130 and drill 91-16007 have been used during the procedure.The screwdriver blade is intended to be used for 2.0/2.3 mm screws, whereas the drill is intended to be used for 2.0/2.3 mm screws up to a length of 7 mm.Conclusively, both blade and drill were appropriate to be used for the affected screw.The following are examples of possible root causes according to the related risk management file: - wrong/ missing information - too much load on implant/ bone (e.G.Due to tmj disorder/disease) - improper insertion/ positioning of implant, - abnormal mental/ physiological condition of patient - wrong implant placement (e.G.Region with reduced bone quality, too much bone compression during screw insertion), - implant was damaged by instrument/screw during bending/shaping/insertion - implant damaged during sterilization (e.G.Gamma radiation) - wrong choice of implant (e.G.Screw too short due to system mixup and / or poorly assembled/used instrument or misleading measuring/identification) 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.If the device will be returned, the investigation will be re-evaluated.
Event or Problem Description
It was reported that screw head had sheared off post-operatively.No medical intervention is required.

• Brand Name: BONE SCREW, CROSS-PIN, DIAM.2.0X6MM, (1/PACKAGE)
• Common Device Name: IMPLANT
• Manufacturer (Section D): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11
• MDR Report Key: 7973821
• Report Number: 0008010177-2018-00102
• Device Sequence Number: 11104837
• Product Code: JEY
• UDI-Device Identifier: 07613154643547
• UDI-Public: 07613154643547
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K022185
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2019

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 Catalogue Number: 50-20406E
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/18/2018
• Supplement Date Received by Manufacturer: 09/18/2018
• Initial Report FDA Received Date: 10/17/2018
• Supplement Report FDA Received Date: 03/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1