MAUDE Adverse Event Report: SYNTHES GMBH ANTIROTATION SCREW FOR FEMORAL NECK SYS 75MM LENGTH - STERIL; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Model Number	04.168.475S
Medical Device Problem Codes	Use of Device Problem (1670); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/17/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Device report from japan reports an event as follows: it was reported that on (b)(6) 2022, the patient underwent the open reduction internal fixation with the fns for the femoral neck fracture.The guidewire measured 72.5 mm, and the surgeon selected 70 mm bolt.However, there were no appropriate size of bolt and antirotation screw.Therefore, the 75 mm bolt and the 75 mm antirotation screw were used.The bolt slid 10 mm.During reaming at 70 mm, it was not possible to ream to the outer cortex, and the bolt was slightly floated.The surgery was completed successfully without any surgical delay.No further information is available.This report is for an antirotation screw for femoral neck sys 75mm length ¿ steril.This is report 2 of 2 for (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.Additional narrative: device available for evaluation: complainant part is not expected to be returned for manufacturer review/investigation.Initial reporter occupation: initial reporter is a synthes employee.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: ANTIROTATION SCREW FOR FEMORAL NECK SYS 75MM LENGTH - STERIL
• Common Device Name: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
• 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: 15950122
• Report Number: 8030965-2022-10864
• Device Sequence Number: 12596353
• Product Code: KTT
• UDI-Device Identifier: 10886982274571
• UDI-Public: (01)10886982274571
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K172872
• 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: Other Health Care Professional
• 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: 04.168.475S
• Device Catalogue Number: 04.168.475S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/17/2022
• Initial Report FDA Received Date: 12/09/2022
• 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: BOLT F/FEM NECK SYST F/CONSTRUCT LENGTH; DRILL BIT Ø4.3 L413; REAMER CPL; UNK - GUIDE/COMPRESSION/K-WIRES
• Patient Sex: Unknown