MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG NEURO SCREWS,CROSS-PIN,SELF-DRILLING, DIAM.1.5X4MM; IMPLANT

Catalog Number	50-15904
Health Effect - Clinical Code	Injury (2348)
Date of Event	08/13/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is not available for evaluation.If additional information is received it will be reported on a supplemental report.Device discarded at facility.
Event or Problem Description
It was reported that during the brain tumor operation, the screw slipped and hit the dura mater of the brain.The dura mater was repaired and the operation was delayed for an hour.
Event or Problem Description
It was reported that during the brain tumor operation, the screw slipped and hit the dura mater of the brain.The dura mater was repaired and the operation was delayed for an hour.
Additional Manufacturer Narrative
The reported event could not be confirmed, because the product is not returned for investigation and the provided information is insufficient.Additional information has been requested in order to provide more details to the reported event.It has not been confirmed that blade 62-15020 was used.This blade is appropriate to be used with the reported screw.The review of the dhr showed that there were no discrepancies reported and that the devices were manufactured according to specification.No product malfunction has been reported.However, the patient had suffered an adverse event.The surgeon exercised more force during screw insertion.As a result, the screw had slipped and had hit the dura mater.Due to the event, there was a surgical delay of one hour.The correspondence with the sales rep shows that the surgeon has repaired the dura mater, and that ¿(¿) no further adverse effect notice[sic] until now.(¿)¿ examples of possible root causes according to the related risk management file are: - inappropriate/wrong handling.- inappropriate/bad design.- insufficient bone-quality/quantity.Based on the performed investigation, and the reported event, there is no product malfunction indicated or any systematic design, material or manufacturing related issue.Therefore no further corrective and / or preventive actions re deemed necessary at this time.The complaint is added to the complaint trend.

• Brand Name: NEURO SCREWS,CROSS-PIN,SELF-DRILLING, DIAM.1.5X4MM
• Common Device Name: IMPLANT
• Manufacturer (Section D): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11
• MDR Report Key: 7898046
• Report Number: 0008010177-2018-00089
• Device Sequence Number: 11150898
• Product Code: JEY
• UDI-Device Identifier: 37613154481775
• UDI-Public: 37613154481775
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• PMA/510(K) Number: K031659
• 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): 03/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 50-15904
• Device Lot Number: 1000282459
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/24/2018
• Supplement Date Received by Manufacturer: 08/24/2018
• Initial Report FDA Received Date: 09/21/2018
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 55 YR