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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER TRAUMA KIEL CLAMPING JAW, YELLOW STAPLE; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
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STRYKER TRAUMA KIEL CLAMPING JAW, YELLOW STAPLE; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT Back to Search Results
Catalog Number 69831020
Device Problems Break (1069); Detachment Of Device Component (1104); Component Falling (1105)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/26/2014
Event Type  malfunction  
Event Description
It was reported that while the surgeon was impacting the stamp, the product broke.The broken piece dropped to the floor.The procedure was delayed less then 10 minutes.It was reported that the product had been in service for 3-5 months.
 
Manufacturer Narrative
Once the investigation has been completed, any additional information will be reported in a supplemental report.
 
Manufacturer Narrative
Evaluation summary: a review of the dhr revealed no discrepancies in material or manufacturing.The jaws have been used frequently until damage during the past 7 years.The failure mode could be assumed in a wrongly assembled staple (in between the jaws behind the intended reception).Tightening then will cause non intended bending forces to the jaws.We regard to the event as user related.
 
Event Description
It was reported that while the surgeon was impacting the stamp, the product broke.The broken piece dropped to the floor.The procedure was delayed less then 10 minutes.It was reported that the product had been in service for 3-5 months.
 
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Brand Name
CLAMPING JAW, YELLOW STAPLE
Type of Device
ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Manufacturer (Section D)
STRYKER TRAUMA KIEL
prof. kuentscher-strasse 1-5
schoenkirchen/kiel D-24 232
Manufacturer (Section G)
STRYKER TRAUMA KIEL
prof. kuentscher-strasse 1-5
schoenkirchen/kiel D-24 232
Manufacturer Contact
rose mincieli
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key3684724
MDR Text Key4236894
Report Number0009610622-2014-00125
Device Sequence Number1
Product Code LXH
Combination Product (y/n)N
Reporter Country CodeCA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 02/28/2014
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 Catalogue Number69831020
Device Lot NumberK886497
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/19/2014
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 04/03/2014
Initial Date FDA Received03/18/2014
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received04/23/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/01/2006
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Other;
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