MAUDE Adverse Event Report: SYNTHES PRODUKTIONS GMBH 1.6MM NON-THREADED GUIDE WIRE TROCAR POINT 220MM; SCREW, FIXATION, BONE

Model Number	02.226.001
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/09/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional narrative: additional device product code: hty.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a j&j sales representative.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 (b)(6) 2020, during an unknown surgery, a cannulated stardrive screwdriver shaft was stripped along with the headless compression screw and five (5) non-threaded guide wires were bent prior to insertion.There was no surgical delay.It is unknown if the procedure was successfully completed.No patient consequence reported.This report is for one (1) 1.6mm non-threaded guide wire trocar point 220mm.This is report 6 of 6 for (b)(4).

• Brand Name: 1.6MM NON-THREADED GUIDE WIRE TROCAR POINT 220MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): SYNTHES PRODUKTIONS GMBH; dornacherstrasse 20; balsthal 4710 ; SZ 4710
• MDR Report Key: 11127330
• Report Number: 8030965-2021-00118
• Device Sequence Number: 19758205
• Product Code: HWC
• UDI-Device Identifier: 10886982057655
• UDI-Public: (01)10886982057655
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K080943
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/09/2020

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 Model Number: 02.226.001
• Device Catalogue Number: 02.226.001
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/09/2020
• Initial Report FDA Received Date: 01/06/2021
• Patient Sequence Number: 1