MAUDE Adverse Event Report: SYNTHES GMBH BOLT FOR FEMORAL NECK SYS 105 LENGTH-S; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Model Number	04.168.305S
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/31/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).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: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.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) 2022, during an fns case, the guidewire was measured to determine the length of the locking bolt.When the stepped reamer was set to the correct length and began to ream, it was realized under x-ray that the measurement was incorrect and the stepped reamer would have penetrated the femoral head if reaming were to be continued.The correct guidewire and measuring device from the fns set was used.The sterile boxed 105mm fns bolt was opened when it was determined it would be the incorrect size.The surgeon attempted to put in the 105mm bolt, but it was going to be to long so a 100mm bolt was opened.It was unknown if there was any patient consequences.This complaint involves one (1) device.This report is for one (1) bolt for femoral neck sys 105 length-s.This is report 1 of 2 for complaint (b)(4).

• Brand Name: BOLT FOR FEMORAL NECK SYS 105 LENGTH-S
• 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): WERK GRENCHEN (CH); solothurnstrasse 186; grenchen 2540 ; SZ 2540
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 16229876
• Report Number: 8030965-2023-00805
• Device Sequence Number: 5351634
• Product Code: KTT
• UDI-Device Identifier: 10886982274779
• UDI-Public: (01)10886982274779
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K172872
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/23/2023

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: 04.168.305S
• Device Catalogue Number: 04.168.305S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/31/2022
• Supplement Date Received by Manufacturer: 02/28/2023
• Initial Report FDA Received Date: 01/23/2023
• Supplement Report FDA Received Date: 02/28/2023
• 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: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - GUIDE/COMPRESSION/K-WIRES; UNK - MEASURING DEVICES: TRAUMA; UNK - REAMERS
• Patient Sex: Unknown