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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LAG SCREW, TI GAMMA3® Ø10.5X95MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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STRYKER TRAUMA KIEL LAG SCREW, TI GAMMA3® Ø10.5X95MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Catalog Number 30600095S
Device Problem Collapse (1099)
Patient Problem No Code Available (3191)
Event Date 01/28/2018
Event Type  Injury  
Manufacturer Narrative
Device will not be returned. If additional information becomes available it will be provided on a supplemental report.
 
Event Description
It was reported that patient's left hip was revised. Patient was revised from a gamma3 construct to a hemi hip construct. Additional information received from rep: revision gamma3, due to collapsed femoral head.
 
Event Description
It was reported that patient's left hip was revised. Patient was revised from a gamma3 construct to a hemi hip construct. Additional information received from rep: revision gamma3, due to collapsed femoral head.
 
Manufacturer Narrative
The reported event that lag screw, ti gamma3® ø10. 5x95mm was alleged of issue k-175 ¿ (implant revision/removal without implant breakage) could not be confirmed, since the device was not returned for evaluation and no other evidences were provided. More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event. Some of the possible root causes could be: patient related: (e. G. Weak areas, focus of tension, traumatic overload, inadequate load or support, abrasion of joints) or user handling failure (e. G. Implant was weakened / damaged when implanted; inadequate reposition, wrong nail geometry chosen, position of implant is incorrect, miss locking, miss drilling) a review of the labeling did not indicate any abnormalities. The operative technique gives clear instruction on the entire procedure including implant size selection to end cap fixation. It also clearly indicates that the ¿each surgeon must consider the particular needs of each patient and make appropriate adjustments when and as required¿ and that the user should ¿ensure that you are familiar with the intended uses, indications/contraindications, compatibility and correct handling of the implant, which are described in the operative technique manual for the product system. ¿ the labelling also mentions ¿deep venous thrombosis & avascular necrosis¿ among possible adverse effects and that the ¿adverse results may be clinically related rather than device related. ¿ a review of the device history for the reported lot did not indicate any abnormalities. No corrective actions are required at this time. The device inspection was not possible as the product was not returned for investigation. If device is returned or any further information is provided, the investigation report will be reassessed.
 
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Brand NameLAG SCREW, TI GAMMA3® Ø10.5X95MM
Type of DeviceROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Manufacturer (Section D)
STRYKER TRAUMA KIEL
prof. kuentscher-strasse 1-5
schoenkirchen/kiel D-242 32
MDR Report Key7297172
MDR Text Key100973984
Report Number0009610622-2018-00054
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
Type of Report Initial,Followup
Report Date 05/02/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/26/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date06/30/2022
Device Catalogue Number30600095S
Device Lot NumberK0B0F39
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/09/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 02/26/2018 Patient Sequence Number: 1
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