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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER TRAUMA KIEL TARGET DEVICE T2 RECON ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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STRYKER TRAUMA KIEL TARGET DEVICE T2 RECON ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Model Number 1806-3100
Device Problem Failure to Align (2522)
Patient Problems Failure of Implant (1924); Unequal Limb Length (4534); Implant Pain (4561)
Event Date 02/15/2021
Event Type  malfunction  
Manufacturer Narrative
Upon completion of the investigation any additional information will be communicated in a supplemental report.
 
Event Description
The customer reported that the patient presented with pain 6 weeks after implantation with a t2 nail. On x-ray it was noted that the screws had not gone through the nail. The surgeon checked the target device prior to the case and also after the case. The customer would like the jig to be inspected. New information and corrections received (b)(6) 2021, according to the adverse incident report: proximal displacement of nail. Patient underwent recon nailing of his right femur on (b)(6) 2021. There were no noticed complications during the procedure. Check x-ray was taken on (b)(6) 2021. No significant problem was identified. Patient reviewed at clinic on (b)(6) 2021. Check x-ray taken showed that there had been proximal displacement of the nail with some collapse and rotation at the fracture site. This was in keeping with the proximal locking screws not being through the nail (allowing proximal migration of the nail). The patient was also sent for an additional true lateral of the hip at that appointment. Patient examined and it was noted that the leg was approximately 2cm short with some slight external rotation of the foot. Patient has subsequently had revision surgery in rvh.
 
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Brand NameTARGET DEVICE T2 RECON
Type of DeviceROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Manufacturer (Section D)
STRYKER TRAUMA KIEL
prof. kuentscher-strasse 1-5
schoenkirchen/kiel D-242 32
GM D-24232
Manufacturer (Section G)
STRYKER TRAUMA KIEL
prof. kuentscher-strasse 1-5
schoenkirchen/kiel D-242 32
GM D-24232
Manufacturer Contact
kristen canter
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key11966698
MDR Text Key256100602
Report Number0009610622-2021-00546
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K102992
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 07/21/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/09/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1806-3100
Device Catalogue Number18063100
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/08/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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