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

Catalog Number	56-15034
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/29/2022
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.
Event or Problem Description
It was reported that during the procedure, while screwing into place, the screw heads broke off and surgeon left the screw shaft in the bone.
Event or Problem Description
It was reported that during the procedure, while screwing into place, the screw heads broke off and surgeon left the screw shaft in the bone.
Additional Manufacturer Narrative
The blade used with the device was 62-15035, lot number unknown.The blade is intended to be used with the reported devices.It was reported that pre-drilling was performed with a medtronic drill using a medtronic drill bit.The reported drill and drill bit are not part of stryker¿s universal neuro iii portfolio.It is mentioned within the related instructions for use (90-02011; 2020-12-01, rev.Aa) that implants, instruments, and accessories within stryker¿s universal neuro iii portfolio are produced and designed to be used together.Further, the use of products from other manufacturers along with stryker products can involve incalculable risks and/or contamination of the material and misalignments of implants and instruments.In sum, the use of a medtronic drill and medtronic drill bit is considered off-label use.Based on the performed statistical investigation, there is no indication of a product malfunction nor any systematic design, material or manufacturing related issue.In addition, intra-operative screw breakage/fracture is not considered a reportable event based on the change in filing decision effective october 25, 2018.Therefore, this mdr # (b)(4) is not considered reportable and the complaint is added to the complaint trend.H3 other text : device not available.

• 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; GM D-79111
• Manufacturer (Section G): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11; GM D-79111
• Manufacturer Contact: rylee koole ; boetzingerstr. 41; freiburg D-791-11 ; GM D-79111 ; 76145120
• MDR Report Key: 14174800
• Report Number: 0008010177-2022-00013
• Device Sequence Number: 14672076
• Product Code: HBW
• UDI-Device Identifier: 37613327090711
• UDI-Public: 37613327090711
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K151387
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/12/2022

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
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/04/2022
• Supplement Date Received by Manufacturer: 04/04/2022
• Initial Report FDA Received Date: 04/21/2022
• Supplement Report FDA Received Date: 07/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown