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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH SYNREAM FLEXSHAFT REAMER

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SYNTHES GMBH SYNREAM FLEXSHAFT REAMER Back to Search Results
Catalog Number 352.040
Device Problem Device-Device Incompatibility (2919)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/26/2020
Event Type  Malfunction  
Manufacturer Narrative

Additional narrative: reporter is jnj representative. The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report. 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 (b)(6) as follows: it was reported that on (b)(6) 2020, the patient underwent the open reduction internal fixation surgery for the femoral subtrochanteric fracture. During the surgery, while assemble the shaft, reamer head and rod to ream the medullary cavity, but the shaft couldn¿t be inserted to the rod and stuck. The surgery was completed successfully within 30 minutes delay. The patient outcome was unknown. Concomitant device reported: unknown reamer head (part# unknown; lot# unknown; quantity: 1). Synream flex shaft (part# 352. 040; lot# 2143748; quantity: 1). This complaint involves two (2) devices. This report involves one (1) unk - drill bits: trauma. This is report 1 of 1 for (b)(4).

 
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Brand NameSYNREAM FLEXSHAFT
Type of DeviceREAMER
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer (Section G)
WERK SYNTHES UMKIRCH (DE)
im kirchenhürstle 4-6
umkirch bei freiburg 79224
GM 79224
Manufacturer Contact
kara ditty-bovard
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key11212664
MDR Text Key228170580
Report Number8030965-2021-00537
Device Sequence Number1
Product Code HTO
Combination Product (Y/N)N
Reporter Country CodeJA
PMA/PMN NumberEXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 12/26/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/22/2021
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number352.040
Device LOT Number2097791
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer01/19/2021
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/16/2021
Was Device Evaluated By Manufacturer? No
Date Device Manufactured12/07/2004
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

Patient TREATMENT DATA
Date Received: 01/22/2021 Patient Sequence Number: 1
Treatment
UNK - REAMERS: REAMER HEAD; UNK - REAMING RODS
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