Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH PROTECTION SLEEVE FOR FNS INSERTION INSTRUMENTS; CANNULA,SURGICAL,GENERAL & PLASTIC SURGERY
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

SYNTHES GMBH PROTECTION SLEEVE FOR FNS INSERTION INSTRUMENTS; CANNULA,SURGICAL,GENERAL & PLASTIC SURGERY Back to Search Results
Catalog Number 03.168.013
Device Problem Device-Device Incompatibility (2919)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/20/2020
Event Type  malfunction  
Manufacturer Narrative
The investigation could not be completed, no product was received.No conclusion could be drawn at the time of filing this report.Device history lot part: 03.168.013, lot: 180067-106, manufacturing site: selzach.Supplier: leitner ag.Release to warehouse date: july 19, 2018.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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 (b)(6) reports an event as follows: it was reported that on (b)(6) 2020, the patient underwent the open reduction internal fixation surgery for the femoral neck medial fracture with the drill bit and sleeve in question.During the screw insertion, the surgeon tried to assemble the drill bit to the sleeve, but when the drill bit was inserted to the sleeve halfway, he couldn't push and pull the drill bit and it stuck to the sleeve.The surgeon removed the devices and implants once, and he could dissemble the drill bit from the sleeve.The surgeon tried to assemble them again out of the body, but he couldn't, too.The surgeon continued the surgery without using the drill bit and sleeve and the surgery was completed successfully.After the surgery when the surgeon tried to pass the drill bit through the sleeve, he had difficulty in assembling them, but he could pass the drill bit through the sleeve.No further information is available.Concomitant device reported: unknown screw (part#: unknown, lot#: unknown, quantity: 1.This complaint involves two devices.This report is for (1)protection sleeve f/insertion instr.This report is 2 of 2 for (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.H10 additional narrative: d7 h3, h6: 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.D1.
 
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.H10 additional narrative: h3, h6: part: 03.168.013 lot: 180067-106 manufacturing site: selzach supplier: leitner ag release to warehouse date: july 19, 2018 a manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.The product was returned to depuy synthes for evaluation.Depuy synthes then conducted visual and functional inspection of the returned device.Visual analysis of the returned protection sleeve determined that the edge at the forefront has a strong deformation.Otherwise, the device is in a good condition with no visible damages, except some slight wear marks.A functional test with the also received drill bit was performed; the drill bit could be inserted and removed without any issues.It was not possible to reproduce the complained malfunction.The deformation at the forefront of the received sleeve has in the received condition no influence on the functionality.Nevertheless, the complaint is rated as confirmed as the visual damages at the shaft of the drill bit indicate that there was an issue during the procedure.This issue was clearly caused by the deformation at the sleeve.The deformation was clearly caused post-manufacturing, either by a hit with another instrument or a drop to the ground.As part of depuy synthes quality process all devices are manufactured, inspected, and released to approved specifications.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post market surveillance.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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
PROTECTION SLEEVE FOR FNS INSERTION INSTRUMENTS
Type of Device
CANNULA,SURGICAL,GENERAL & PLASTIC SURGERY
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ  4436
MDR Report Key11023175
MDR Text Key243583280
Report Number8030965-2020-09811
Device Sequence Number1
Product Code GEA
UDI-Device Identifier07611819657397
UDI-Public(01)07611819657397
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup
Report Date 11/20/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/16/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number03.168.013
Device Lot Number180067-106
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/19/2021
Date Manufacturer Received02/11/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
DRILL BIT Ø4.3 L413; UNK - SCREWS: TRAUMA
-
-