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: ARTHREX, INC. BIO-COMP SWVLK SP, 4.75X24.5MM; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
  • 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
 

ARTHREX, INC. BIO-COMP SWVLK SP, 4.75X24.5MM; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE Back to Search Results
Model Number BIO-COMP SWVLK SP, 4.75X24.5MM
Health Effect - Clinical Code No Information (3190)
Date of Event 04/04/2018
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was expected but has not returned for evaluation.The cause of the event could not be determined from the information available and without device evaluation.
 
Event or Problem Description
It was reported that during a rupture of the supraspinatus tendon surgery the swivelock broke off when turning in.Additional information obtained 12 june 2018: the surgery was completed successfully with a new device of the same part number.The new device was placed on a different spot - it is not covering the broken anchor.The anchor broke and 2/3 of the anchor will remain inside the bone well fixed.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
BIO-COMP SWVLK SP, 4.75X24.5MM
Common Device Name
FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
Manufacturer (Section D)
ARTHREX, INC.
1370 creekside boulevard
naples FL 34108 1945
MDR Report Key7624842
Report Number1220246-2018-00512
Device Sequence Number19287348
Product Code MAI
UDI-Device Identifier00888867026865
UDI-Public00888867026865
Combination Product (Y/N)N
Initial Reporter CountryGM
PMA/510(K) Number
K101823
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 06/21/2018
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? No
Operator of Device No Information
Device Model NumberBIO-COMP SWVLK SP, 4.75X24.5MM
Device Catalogue NumberAR-2324BCM
Device Lot NumberF159278
Was Device Available for Evaluation? Yes
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/05/2018
Initial Report FDA Received Date06/21/2018
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
-
-