MAUDE Adverse Event Report: SYNTHES GMBH BLADE/SCREW GUIDE SLEEVE; GUIDE, SURGICAL, INSTRUMENT

Catalog Number 03.037.017

Device Problems Device-Device Incompatibility (2919); Material Twisted/Bent (2981); Mechanical Jam (2983)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/18/2023

Event Type  malfunction  

Event Description

Surgeon was performing a proximal femoral nailing system (tfna) on a very obese patient.The aiming arm locking clip, insertion guide and pin wrench were all damaged and would no longer further advance or retract due to all the adipose tissue.All instruments were completely jammed, threads were damaged and no longer able to be separated.No patient issues and surgery was completed successfully.No further information is available.There was no surgical delay.The procedure was successfully completed.This complaint involves six(6) devices.This report is for one (1).Blade/screw guide sleeve.This is report 2 of 5 for complaint (b)(4).

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: d9: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.D10: date of concomitant therapy is (b)(6) 2023.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.

• Brand Name: BLADE/SCREW GUIDE SLEEVE
• Type of Device: GUIDE, SURGICAL, INSTRUMENT
• 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: 17878247
• MDR Text Key: 325359109
• Report Number: 8030965-2023-12626
• Device Sequence Number: 1
• Product Code: FZX
• UDI-Device Identifier: 10886982070333
• UDI-Public: (01)10886982070333
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.037.017
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: 125 DEG AIMING ARM.; 4.5MM PIN WRENCH 120MM.; AIMING ARM LOCKING DEVICE.; BUTTRESS/COMPRESSION NUT.; CANNULATED CONNECTING SCREW.