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 Known Impact Or Consequence To Patient (2692)
Date of Event	03/09/2019
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.Distributor cannot return for evaluation.
Event or Problem Description
It was reported by the distributor that there was an issue during a hydrocephalus case.While the surgeon was implanting a screw he could not properly drive screw into the skull as it kept slipping.There was no significant delay or patient harm reported.

• 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: 8617849
• Report Number: 0008010177-2019-00016
• Device Sequence Number: 16217343
• 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
• Report Date (Section B): 05/16/2019

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/10/2019
• Initial Report FDA Received Date: 05/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1