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U.S. Department of Health and Human Services

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

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SYNTHES GMBH SYNREAM REAMER HEAD Ø8.5 Back to Search Results
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.
 
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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 Key16700880
MDR Text Key312874374
Report Number8030965-2023-04304
Device Sequence Number1
Product Code HTO
UDI-Device Identifier07611819243699
UDI-Public(01)07611819243699
Combination Product (y/n)N
Reporter Country CodeUK
Number of Events Reported1
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 Number352.085
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/20/2023
Initial Date FDA Received04/07/2023
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 Number1
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;
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