MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG UN3 SCREWS, SELF-DRILLING, 1.5X4MM, 5/P; IMPLANT

Catalog Number	56-15904
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/25/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not available for evaluation.If additional information is received it will be reported on a supplemental report.
Event or Problem Description
It was reported by a distributor that during a surgical procedure it was found that screw slippage was making it difficult to pick up the designated screws, and once picked up the screws slipped.There was no medical intervention, and there were no adverse consequences with this event.The procedure was completed successfully.
Additional Manufacturer Narrative
The reported device was not returned for evaluation, thus the reported event could not be confirmed.In the reported event it was stated that instead of using 8 screws, the surgeon used a total of 15 screws due to some screw damages.It is most likely that these damages incurred during screw pick-ups.Further, it was also mentioned that the surgeon also spent more time removing the damaged screws.There was a surgical delay of at least 20 minutes.Additional information was requested in order to provide more details to the reported event.In a follow-up email, it was mentioned that blades 62-15030 and 62-15032 were used during the procedure.These blades are appropriate to be used with the reported screw.No pre-drilling was performed.However, in the instructions for use (ifu # 90-02011, rev.12), it is stated that if it is difficult for self-drilling screws to start or insert into the bone, pilot holes should be drilled.Furthermore, the review of the related dhr of the device in question has shown that it was manufactured to specification and was accepted into final stock without any reported discrepancies.Possible root causes according to the related risk management file are: insufficient bone-quality/quantity implant damage/breakage due to compromised mechanical strength of implant/instrument (inappropriate handling) insufficient handling properties with gloves (inappropriate handling) too less implant-instrument connection (too less axial force during screw pick-up; use of damaged screw driver blade) too high forces during implantation (too less implant-instrument connection) too less fixation of implant to bone excessive force on bone (wrong handling) 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 or Problem Description
It was reported by a distributor that during a surgical procedure it was found that screw slippage was making it difficult to pick up the designated screws, and once picked up the screws slipped.There was no medical intervention, and there were no adverse consequences with this event.The procedure was completed successfully.

• Brand Name: UN3 SCREWS, SELF-DRILLING, 1.5X4MM, 5/P
• Common Device Name: IMPLANT
• Manufacturer (Section D): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11
• MDR Report Key: 8632039
• Report Number: 0008010177-2019-00021
• Device Sequence Number: 1748372
• Product Code: HBW
• UDI-Device Identifier: 34546540684920
• UDI-Public: 34546540684920
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• PMA/510(K) Number: K112557
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/08/2019

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: 56-15904
• Device Lot Number: 1000297572
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/10/2019
• Supplement Date Received by Manufacturer: 05/10/2019
• Initial Report FDA Received Date: 05/22/2019
• Supplement Report FDA Received Date: 11/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1