MAUDE Adverse Event Report: SYNTHES GMBH SYNREAM REAMER HEAD Ø8.5

Catalog Number 352.085

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 03/20/2023

Event Type  Injury  

Event Description

Device report from synthes reports an event in united kingdom as follows: it was reported on (b)(6) 2023, that the ria 2 system was used in the tibia, the surgeon allowed a registrar to handle the system.Unfortunately the reamer head detached from the system and metal shards came off in the patient.Although i stated that the angle should not surpass 10 degrees as there is too much flexion in the drive shaft this wasn¿t listened to, and the surgeon accepted that too much pressure was put on the system in this instance.We then went to use the standard syn ream system, however as i was between theatres the scrub staff hadn¿t noticed that the stryker power tool needed to be adjusted back to the ream setting from the drill setting which led to the wire bending, and bone burning inside of the patient, damaging the syn ream head (8.5) and syn ream flexible shaft.The stryker system 7 power tool was used, which delivers an incorrect torque on the ria 2 system of 17nm rather than the recommended 3.5-6nm.This was not known at the time.The syn ream system was then used before moving back to the ria 2 system.There was surgical delay.The surgery was not successful.The system was not successful so the surgeon washed out the im canal as best as possible without the ria 2.Patient status/ outcome: higher risk of infection not clearing but no official outcome reported yet.Concomitant devices reported: unk - drill bits: trauma (part # unknown, lot # unknown, quantity # unknown) and unk - guide/compression/k-wires: viper (part # unknown, lot # unknown, quantity 1).This report is for one (1) synream reamer head ø8.5 this is report 2 of 5 for complaint :# (b)(4).

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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Additional narrative: complainant part is not expected to be returned for manufacturer review/investigation.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: SYNREAM REAMER HEAD Ø8.5
• Type of Device: REAMER
• 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: 16700880
• MDR Text Key: 312874374
• Report Number: 8030965-2023-04304
• Device Sequence Number: 1
• Product Code: HTO
• UDI-Device Identifier: 07611819243699
• UDI-Public: (01)07611819243699
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 352.085
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/20/2023
• Initial Date FDA Received: 04/07/2023
• 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: REAMER HEAD F/RIA 2 Ø10.5; REAMROD Ø2.5 L950 W/OLIVE; RIA 2 BONE HARVESTING KIT L520; SYNREAM FLEXSHAFT; UNK - DRILL BITS: TRAUMA; UNK - GUIDE/COMPRESSION/K-WIRES: VIPER; UNK - POWER ACCESSORIES
• Patient Outcome(s): Required Intervention