MAUDE Adverse Event Report: SYNTHES GMBH AIM ARM/LAT/F/MULTILOC PROXIMAL HUM NL; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	03.019.008
Medical Device Problem Codes	Device-Device Incompatibility (2919); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: e3: reporter is a j&j employee.D9: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.H3, h4, h6: 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 an unknown date during a multiloc procedures, the drill bit hit the nail for the posterior, anterior and direct anterior screw.The sleeves were tested before and unsure what happened.Perfect circle procedure was performed proximally.There was a patient delay.It was unsure that the jig was bent or not due to rotating jig intraop, but surgeon wants everything replaced.There was a surgical delay of 5 minutes.There was no patient consequences.This report is for one (1) aim arm/lat/f/multiloc proximal hum nl this is report 2 of 9 for complaint (b)(4).

• Brand Name: AIM ARM/LAT/F/MULTILOC PROXIMAL HUM NL
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• 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: 18632801
• Report Number: 8030965-2024-01878
• Device Sequence Number: 7889525
• Product Code: HSB
• UDI-Device Identifier: 10886982069450
• UDI-Public: (01)10886982069450
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K103002
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/02/2024

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 Catalogue Number: 03.019.008
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/22/2024
• Initial Report FDA Received Date: 02/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 5.8MM/2.8MM DRILL SLEEVE FOR 03.019.019; AIM ARM/ANT/F/MULTILOC PROXIMAL HUM NL; AIMING ARM FOR MULTILOC HUMERAL NAIL; CENT SLV 3.5 TI LCK SCR/4.5 TI MULILC SC; CONNECTING SCRECANN FOR MULTILOC HUM NL; INSRT HNDL FOR MULTILOC HUM NLING SYS; UNK - DRILL BITS: TRAUMA; UNK - NAILS
• Patient Sex: Unknown