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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER TRAUMA KIEL U-BLADE LAG SCREWDRIVER GAMMA3® ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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STRYKER TRAUMA KIEL U-BLADE LAG SCREWDRIVER GAMMA3® ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Catalog Number 13200310
Device Problems Break (1069); Difficult to Insert (1316)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 05/16/2017
Event Type  malfunction  
Manufacturer Narrative
The evaluation revealed the gama3 u-blade lag screwdriver to be the primary product. No deviations were found during review of the manufacturing and inspection documents (dhr). The item returned was documented as faultless prior to distribution. As the device had been in use for approx. 3 years we pre-suppose that it had fulfilled its tasks in former surgeries as intended. During investigation no material, dimensional or manufacturing related issues were found. The pegs of the screwdriver hull were found completely broken off; the deformations of the pegs rest material show that the pegs were sheared off. The threaded tip of the screwdriver rod is deformed; some windings are partly flattened and abraded. Due to the damages the rod was not fully insertable into the hull. The found damages indicate that the screwdriver was assembled to a u-blade lag screw; during the lag screw insertion the materials of the hull and rod were torsional overloaded. The customer reported that the u-lag screw was not inserted properly; maybe the target device was defective. Most likely the lag screw got in contact to the proximal nail hole rim and surface, causing resistance against the insertion. The ifu includes that all instruments shall be checked prior usage; a defective target device would have been detected prior surgery. Furthermore all instruments shall be handled with care and used according to the operative technique. Because no manufacturer related issues were detected the case is attributed to an inadequate usage (user related). Review of complaint history, capa databases, risk analysis and labelling did not identify any discrepancies. There are no open actions in place related to the reported event for the subject product(s). No non-conformity was identified.
 
Event Description
Primary surgery using t2r was performed on (b)(6) 2014. After that the fracture did not heal and revision surgery using g3l was performed on (b)(6) 2017. During g3l surgery, as lag screw guide wire induced to the hole of the t2r lag screw, it was not inserted properly. The surgeon gave up the step drill procedure and inserted u-lag screw to the patient. Also the u-lag screw was not inserted properly, the tip of the u-lag screw driver broke after repeated trial and error. The surgery was finished with the screw projecting to lateral slightly. U-blade and u-endcap were not used. This pi to cover the breakage the u-lag screw driver and related to pi (b)(4).
 
Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
 
Event Description
Primary surgery using t2r was performed on (b)(6)2014. After that, the fracture did not heal and revision surgery using g3l was performed on (b)(6)2017. During g3l surgery, as lag screw guide wire induced to the hole of the t2r lag screw, it was not inserted properly. The surgeon gave up the step drill procedure and inserted u-lag screw to the patient. Also the u-lag screw was not inserted properly, the tip of the u-lag screw driver broke after repeated trial and error. The surgery was finished with the screw projecting to lateral slightly. U-blade and u-endcap were not used. This pi to cover the breakage the u-lag screw driver and related to (b)(4).
 
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Brand NameU-BLADE LAG SCREWDRIVER GAMMA3®
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 Key6625526
MDR Text Key207095856
Report Number0009610622-2017-00179
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
PMA/PMN Number
K032244
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 08/03/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/08/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number13200310
Device Lot NumberK0ADD28
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/23/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/11/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/14/2014
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 06/08/2017 Patient Sequence Number: 1
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