MAUDE Adverse Event Report: SYNTHES GMBH 6.5MM CANNULATED SCREW 16MM THREAD 90MM; SCREW, FIXATION, BONE

Model Number	208.413
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/28/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint #(b)(4).Idepuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Additional narrative: complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported that on february 28, 2023, during intra-op while repositioning a screw intraoperatively, a 2.8 wire became lodged inside a 6.5 cannulated screw.The surgical tech said the wire had been bent intra-op so there was no allegation against the products.The wire was removed and a new wire was selected and screw was implanted.No adverse events occurred.There was no reported surgical delay.Procedure was completed successfully.There was no fragments completed.It was unknown if were they removed easily without additional intervention.There was no patient consequences.This complaint involves two (2) devices.This report is for one (1) 6.5mm cannulated screw 16mm thread 90mm this is report 1 of 2 for complaint (b)(4).

• Brand Name: 6.5MM CANNULATED SCREW 16MM THREAD 90MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 16549817
• Report Number: 8030965-2023-03197
• Device Sequence Number: 6490355
• Product Code: HWC
• UDI-Device Identifier: 10886982149206
• UDI-Public: (01)10886982149206
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K161616
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial

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
• Device Model Number: 208.413
• Device Catalogue Number: 208.413
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/28/2023
• Initial Report FDA Received Date: 03/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 2.8 THRD GUIDE WIRE- TROCAR POINT 300
• Patient Sex: Female