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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG., XL ANGLED TOMCAT LONG HIP BLADE F-SERIES -4.0MM; BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL
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STRYKER ENDOSCOPY-SAN JOSE PKG., XL ANGLED TOMCAT LONG HIP BLADE F-SERIES -4.0MM; BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL Back to Search Results
Catalog Number 0385545100
Device Problems Break (1069); Component Falling (1105)
Patient Problem No Code Available (3191)
Event Date 01/12/2018
Event Type  Injury  
Manufacturer Narrative
Additional information will be provided once the investigation has been completed.(b)(4).
 
Event Description
It was reported that the tip of the 4.0mm formula xl tomcat angled hip cutter broke off into the joint space.The tip was found and removed after the case was converted to open procedure with a total delay of approximately 90 minutes.The case was completed successfully.
 
Manufacturer Narrative
(b)(4).Alleged failure: tip broke off.Probable root cause: material strength (design).The product was not returned for investigation therefore the reported failure mode was not confirmed.The reported failure mode will be monitored for future reoccurrence.
 
Event Description
It was reported that the tip of the 4.0mm formula xl tomcat angled hip cutter broke off into the joint space.The tip was found and removed after the case was converted to open procedure with a total delay of approximately 90 minutes.The case was completed successfully.
 
Manufacturer Narrative
The product was not returned for investigation therefore the reported failure mode was not confirmed.Alleged failure: tip broke off.Probable root cause: inadequate window profile, inadequate welding process (i.E.Plasma, inductive, gluing), improper material strength, inadequate size selected for the application, material brittleness , excessive force applied by the user, incorrect rfid tag.The reported failure mode will be monitored for future reoccurrence.
 
Event Description
It was reported that the tip of the 4.0mm formula xl tomcat angled hip cutter broke off into the joint space.The tip was found and removed after the case was converted to open procedure with a total delay of approximately 90 minutes.The case was completed successfully.
 
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Brand Name
PKG., XL ANGLED TOMCAT LONG HIP BLADE F-SERIES -4.0MM
Type of Device
BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL
Manufacturer (Section D)
STRYKER ENDOSCOPY-SAN JOSE
5900 optical court
san jose CA 95138
MDR Report Key7259657
MDR Text Key99581034
Report Number0002936485-2018-00106
Device Sequence Number1
Product Code GFA
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
Type of Report Initial,Followup,Followup
Report Date 03/06/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/09/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number0385545100
Device Lot Number17227CE2
Was Device Available for Evaluation? No
Date Manufacturer Received01/12/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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