MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG UNIII AXS SCREWS,AXS,ST,1.5X4MM,5/P; IMPLANT

Catalog Number	56-15034
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/17/2018
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.Screw body still in patient; screw head discarded at facility.
Event or Problem Description
It was reported by the company representative that the screw head broke off during insertion.The body of the screw was left in the patient.There was no adverse consequence nor delay of surgery reported.
Additional Manufacturer Narrative
Since the device was not returned, a confirmation of the reported event is not applicable.In a follow-up email, the sales representative has stated that during procedure the screwdriver blade 62-15035 has been used.This screwdriver blade is intended to be used for stryker universal neuro iii axs screws.Further, he also mentioned that ¿the surgeon pre-drilled a pilot hole using a midas stylus electric drill with their 1.1mm part # 8td104.¿ as stated in the instructions for use ¿use of original products: stryker universal neuro iii implants, instruments and accessories are produced and designed to be used together.¿ therefore the root cause for the intraoperative screw breakage could be attributed to an off-label use, being that the surgeon has used a drill, a midas stylus electric drill, which is not part of the stryker neuro implant system.Based on statistical evaluation there are no indications for any systematic design, material or manufacturing related issue.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 by the company representative that the screw head broke off during insertion.The body of the screw was left in the patient.There was no adverse consequence nor delay of surgery reported.

• Brand Name: UNIII AXS SCREWS,AXS,ST,1.5X4MM,5/P
• Common Device Name: IMPLANT
• Manufacturer (Section D): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11
• MDR Report Key: 7920223
• Report Number: 0008010177-2018-00095
• Device Sequence Number: 1449466
• Product Code: HBW
• UDI-Device Identifier: 37613327090711
• UDI-Public: 37613327090711
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: K151387
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/16/2018

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: 56-15034
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/17/2018
• Supplement Date Received by Manufacturer: 09/17/2018
• Initial Report FDA Received Date: 09/28/2018
• Supplement Report FDA Received Date: 11/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1