• 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 STRAIGHT BALL SPIKE FOR LOW PROFILE PELVIC SYSTEM; RETRACTOR

  • 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 STRAIGHT BALL SPIKE FOR LOW PROFILE PELVIC SYSTEM; RETRACTOR Back to Search Results
Model Number 03.100.018
Device Problem Contamination /Decontamination Problem (2895)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 (b)(6) as follows: it was reported that, the non-acceptance of the instrument with cable in celeron material by the (b)(6) hospital materials center, we consulted with nurse (b)(6), responsible for the technical area of the hospital's materials center.It is a material that has porosity due to exposure to the temperature of the sterilization process.It is the porosity of the celeron that compromises the cleaning process.It was understood then that the material compromises the sterilization process, since it has porosity that does not guarantee the effectiveness of cleaning.If you are not in accordance with the justification presented, i suggest that you present to the hospital technicians responsible, a document with the manufacturer's specifications that meet the standards of the manuals of good cleaning and sterilization practices.This report is for one (1) straight ball spike for low profile pelvic system.This is report 3 of 15 for complaint (b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
STRAIGHT BALL SPIKE FOR LOW PROFILE PELVIC SYSTEM
Type of Device
RETRACTOR
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ  4436
MDR Report Key11863312
MDR Text Key280522989
Report Number8030965-2021-04121
Device Sequence Number1
Product Code GAD
UDI-Device Identifier10886982070678
UDI-Public(01)10886982070678
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,health pr
Type of Report Initial
Report Date 04/23/2021
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
Device Model Number03.100.018
Device Catalogue Number03.100.018
Device Lot NumberT180075
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 04/23/2021
Initial Date FDA Received05/21/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
BALL SPIK STRAIG LONG 6.5 L400; BEND-IRON F/LCP PILON-PL 2.7/3.5 L190; CABLE PASSER LRG; CABLE PASSER LRG 45° ANGLE; CABLE PASSER LRG CURV; CABLE PASSER MED; CABLE PASSER MED 45° ANGLE; CUTT-PLIERS W/POSITION-PIN Ø3; HAND F/TORQUE LIMITER NOS. 511.770+511.7; HANDLE W/QUICK-COUPL; PERIOST-ELEV SLIGHTLY CURV-BLADE ROUND E; RATCHET-HANDLE W/AO/ASIF-QC; SCRDRIVER-HEX ÿ2.5 W/GROOVE; SCRDRIVER-HEX-SMALL Ø2.5 L270; UNKNOWN SYN PRODUCT
-
-