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: STRYKER SPINE-US AVS PL INSERTER 8 AND 9MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
  • 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
 

STRYKER SPINE-US AVS PL INSERTER 8 AND 9MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT Back to Search Results
Model Number 48350951
Device Problems Break (1069); Disconnection (1171); Material Deformation (2976)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/08/2018
Event Type  malfunction  
Event Description
It was reported that upon starting ratcheting the instrument wasn't disconnecting from the implant and broke.Tight space was observed.The procedure was successfully completed and there are no reports of adverse consequences to the patient.
 
Manufacturer Narrative
Method: visual inspection, device history review, complaint history review, risk assessment; result: upon visual inspection, the tip of the instrument was confirmed to be deformed and the inner shaft was found to be slightly bent.No adverse consequences to the patient was reported.Manufacturing history was reviewed and no issues were identified.The age of the device was found to be more than 13 years.The ifu for instruments states that the instruments may fracture depending on the age of the device, the number of times they are used as well as the precautions taken in handling, cleaning and storage.Conclusion: based on the device inspection and provided information, probable root causes of the reported event are: extensive use of the instrument and normal wear and tear.
 
Event Description
It was reported that upon starting ratcheting the instrument wasn't disconnecting from the implant and broke.Tight space was observed.The procedure was successfully completed and there are no reports of adverse consequences to the patient.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
AVS PL INSERTER 8 AND 9MM
Type of Device
ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Manufacturer (Section D)
STRYKER SPINE-US
2 pearl court
allendale NJ 07401
MDR Report Key7311386
MDR Text Key101697510
Report Number0009617544-2018-00058
Device Sequence Number1
Product Code LXH
UDI-Device Identifier07613327267914
UDI-Public(01)07613327267914
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 06/26/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/02/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number48350951
Device Catalogue Number48350951
Device Lot Number058851
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/12/2018
Date Manufacturer Received05/31/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-