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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER TRAUMA KIEL TROCHANTERIC NAIL KIT, TI GAMMA3® Ø11X180MM X 125° ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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STRYKER TRAUMA KIEL TROCHANTERIC NAIL KIT, TI GAMMA3® Ø11X180MM X 125° ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Catalog Number 31251180S
Device Problems Break (1069); Entrapment of Device (1212); Device Slipped (1584); Sticking (1597); Obstruction of Flow (2423); Mechanical Jam (2983)
Patient Problem No Information (3190)
Event Date 09/09/2016
Event Type  malfunction  
Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
 
Event Description
Gamma 3 short nail implant set screw jammed, when the set screw was inserted into the nail it screwed in to a locking point which did not engage the lag screw, on attempt to remove the set screw the flexible screwdriver 'broke', unraveled and the set screw remained stuck in the nail. Surgeon commented may have gotten some tissue stuck on the set screw when inserting.
 
Manufacturer Narrative
Evaluation revealed the trochanteric nail kit and the set screwdriver flexible shaft to be the subject products. No further associated products were reported. Review of the device history records revealed no discrepancies. The items returned were documented as faultless prior to distribution. As the set screwdriver had been in use for more than 5 years, we pre-suppose that the device had fulfilled its tasks in former surgeries as intended. During investigation no material, design or manufacturing related issues were found. The thread of the set screw was found to be plastically deformed. The damage observed was most likely caused by an oblique insertion. Material displacement was caused by the contact with a hard object during the insertion procedure of the set screw. Flattened tips with differing intensity identified a kind of cross threading. The found damages on the set screw were not manufacturing resp. Not device related. Functional and dimensional check revealed the inner thread of the nail to be in accordance to specs. Using an undamaged sample set screw, it could be confirmed that the inner thread of the nail functioned as intended. The damage of the set screw most likely occurred during a misaligned insertion when it was guided in such a manner that is caused excessive contact to the hard metal nail adapter of the target device. Once having overcome the metal part, the assembly of set screw and set screwdriver is guided within the tube of the target device. To mitigate this procedure a 'closed tube clip' had already been developed and introduced into the market. Although not mandatory this instrument was offered to support and to ease the set screw insertion. The tip and the flexible spring of the set screwdriver was found to be bent and deformed. The flexible spring was furthermore partly uncoiled. The appearance and the extent of the damage indicated that too high torque forces had been applied onto the set screwdrivers while removing the set screw. In case of intended use such damage would not have occurred. The operative technique includes that the screwdriver shall only be used to insert set screws; for extraction a straight non-flexible screwdriver shall be used. Based on the above facts the root cause was not related to a deficiency of the devices, but was rather linked to a sub-optimal intra-operative procedure at the user site. Review of complaint history, capa databases and risk analysis did not identify any discrepancies. There are no open actions in place related to the reported event for the subject products. No non-conformity was identified.
 
Event Description
Gamma 3 short nail implant set screw jammed, when the set screw was inserted into the nail it screwed in to a locking point which did not engage the lag screw, on attempt to remove the set screw the flexible screwdriver 'broke', unraveled and the set screw remained stuck in the nail. Surgeon commented may have gotten some tissue stuck on the set screw when inserting.
 
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Brand NameTROCHANTERIC NAIL KIT, TI GAMMA3® Ø11X180MM X 125°
Type of DeviceROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Manufacturer (Section D)
STRYKER TRAUMA KIEL
prof. kuentscher-strasse 1-5
schoenkirchen/kiel D-242 32
Manufacturer (Section G)
STRYKER TRAUMA KIEL
prof. kuentscher-strasse 1-5
schoenkirchen/kiel D-242 32
Manufacturer Contact
anna jusinski
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key5989892
MDR Text Key56553654
Report Number0009610622-2016-00460
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeAU
PMA/PMN Number
K034002
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/22/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/30/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/31/2021
Device Catalogue Number31251180S
Device Lot NumberKO697AD
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/14/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/25/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/14/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 09/30/2016 Patient Sequence Number: 1
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