MAUDE Adverse Event Report: SYNTHES GMBH UNK - REAMERS

Device Problem Improper or Incorrect Procedure or Method (2017)

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

Event Date 06/16/2023

Event Type  malfunction  

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.H10 additional narrative: d9: complainant part is not expected to be returned for manufacturer review/investigation.E3: reporter is a j&j employee.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 Description

Device report from synthes reports an event in japan as follows: it was reported that on (b)(6), 2023, the patient underwent orif surgery for a subtrochanteric fracture.After placing an lcp plate on the anterior lateral, the tfna nail was inserted.Everything went well until the insertion of the nail, but when reaming for the blade, a guide wire remained in the hollow of the reamer, so another guide wire was opened and reinserted, and blade insertion was attempted.The sales rep suggested that the surgeon check the condition of the blade with m-l images because it seemed that the blade was clearly not positioned in the optimal position.It was found that the blade was inserted out of the blade hole.The surgeon reinserted the blade, but the blade could not be inserted easily because the surgeon pushed an aiming arm back and forth to reinsert the blade.After confirming that there were no abnormalities, the surgeon tried to reinsert the blade, but it could not be inserted properly, so the surgeon decided to remove the nail once and check the condition of the implants.The nail was checked to see if there were any connection defects with the blade.There was no loosening or connection defect, but it was found that the blade hole of the nail had been severely shaved by the reamer.Therefore, the nail was replaced with a 125°, 9mm¿340mm one and inserted.A guide wire was then inserted, but the procedure did not proceed well, so a surgeon higher up than the primary surgeon performed a recovery, including the urgent addition of cement.The surgery was completed successfully with a 60-minute delay.The scheduled surgery time was 2 hours.The surgeon higher up than the primary surgeon commented that the event was caused by the technical error of the primary surgeon and the poor judgment and skill of the assistant surgeon.There was no comment that the products caused the event.No further information is available.Concomitant device reported: unk - biomaterial - cement (part# unknown; lot# unknown; quantity: unknown) unk - plates: lcp (part# unknown; lot# unknown; quantity: unknown) this report is for one (1)unk - reamers this is report 5 of 5 for (b)(4).

• Brand Name: UNK - REAMERS
• Type of Device: REAMER
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA ; 3035526892
• MDR Report Key: 17287242
• MDR Text Key: 319135611
• Report Number: 8030965-2023-08502
• Device Sequence Number: 1
• Product Code: HTO
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• 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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/16/2023
• Initial Date FDA Received: 07/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: TFNA FEM NAIL Ø10 R 125° L340 TIMO15; UNK - BIOMATERIAL - CEMENT; UNK - GUIDE/COMPRESSION/K-WIRES; UNK - GUIDES/SLEEVES/AIMING: AIMING ARM; UNK - NAIL HEAD ELEMENTS: TFNA HELICAL BLADE; UNK - PLATES: LCP