MAUDE Adverse Event Report: SYNTHES GMBH CANN-LOCKSCR ø5 L85 TAN; PLATE, FIXATION, BONE

Model Number	04.205.085
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/28/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Device report from synthes reports an event in japan as follows: it was reported that on (b)(6) 2022, the patient underwent the surgery for distal femur fracture with the product in question.The surgeon decided to replace the screw in the distal 4th hole after implantation was completed and confirmed with an image.When he pulled out the screw he used the electric screwdriver, he mistakenly turned the power in forward rotation to fix the screw to the plate.Subsequently, an attempt was made to remove it with a screwdriver, but the screw hole was stripped, and the extraction was abandoned and the wound was closed.The surgeon has confirmed by x-ray that there are no broken pieces or other residuals in the body.Patient status/ outcome is stable.No further information is available.Concomitant detail: unk - screwdrivers: trauma, (part# unknown, lot# unknown, quantity# 1).Unk - plates: trauma, (part# unknown, lot# unknown, quantity# 1).This report is for one (1) cann-lockscr ã¸5 l85 tan.This is report 1 of 1 for complaint (b)(4).
Additional Manufacturer Narrative
Depuy 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.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.

• Brand Name: CANN-LOCKSCR ø5 L85 TAN
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 15995602
• Report Number: 8030965-2022-11201
• Device Sequence Number: 17664607
• Product Code: HRS
• UDI-Device Identifier: 10886982116437
• UDI-Public: (01)10886982116437
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K023802
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,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
• Operator of Device: Health Professional
• Device Model Number: 04.205.085
• Device Catalogue Number: 04.205.085S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/28/2022
• Initial Report FDA Received Date: 12/16/2022
• 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: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN - PLATES: TRAUMA.; UNKNOWN - SCREWDRIVERS: TRAUMA.
• Patient Sex: Unknown