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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER TRAUMA KIEL UNKNOWN LONG GAMMA3 NAIL ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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STRYKER TRAUMA KIEL UNKNOWN LONG GAMMA3 NAIL ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Catalog Number UNK_KIE
Device Problems Break (1069); Device Operates Differently Than Expected (2913)
Patient Problem Pain (1994)
Event Date 11/14/2016
Event Type  Injury  
Manufacturer Narrative
Device will not be returned. If additional information becomes available it will be provided on a supplemental report. Device was discarded.
 
Event Description
It was reported that on unknown date, patient was implanted with unknown gamma3 short nail for multiple injury and femoral neck fracture. On (b)(6) 2016, surgical treatment again by gamma3 long due to nonunion of the femoral neck fracture. On middle of nov, the patient visited the hospital for pain and it was confirmed that the gamma 3 long was broken. On (b)(6) 2016, it will be treated by unk nail again.
 
Manufacturer Narrative
The evaluation revealed the broken gamma3 long nail to be the primary product. As no item was returned function and dimension could not be checked. The device history could not be reviewed because a lot-no was not provided. An investigation of the nail itself was not possible because it was not provided. General aspects: the gamma3 nail is a temporary implant which inevitably will be subject of a fatigue fracture if the biomechanical stresses on the implant are too high or not considerably reduced during the period of implantation. During this period there is a race between bony consolidation / fracture healing and implant breakage as noted in the labelling of the product. Usually a breakage is contributed by one or more deficits, e. G. Insufficient bone healing, product damage. Generally the risk of a breakage will increase with the increase of load cycles and load level. Nail breakage in general has been experienced, but does not present an unanticipated event in itself. Depending on load application, also, depending on the patient¿s post implant behaviour and depending on suitable anatomical reduction, depending on the kind of bone breakage, depending on the course of bone healing and other factors ¿ e. G. Increased post-operative activities - a nail breakage can rather be classified as anticipated ¿ specifically if one or more contributing issues concurrence with each other. One requirement for successful nail treatment is a timely bone healing in order to relive the nail over the progressing time of implantation. Another requirement is that the implant must not be damaged during and after insertion. Surface damages reduce the implant¿s durability significantly. A third requirement is that the implant must not be stressed by too high load application e. G. (but not limited to) exceeding weight bearing or overweight or other stresses. Another requirement is that the gamma3 nail must not be used for medial neck fractures. In this case the patient had initially been revised due to non-union of a neck fracture. The kind of neck fracture was not specified ¿ thus, it could not be determined if the used nail was suitable for this indication. It could not be determined whether the nail had been damaged intra-operatively nor if the nail had been placed according to the anatomical requirements respt. If bone fragment reduction was adequate. As no medical records were presented the course of bone healing could not be determined in this case. As the broken long nail had been implanted for more than 6 months and as the patient had suffered from non-union previously an insufficient bone healing could not be excluded for this case. With available information it could not be excluded that the nail most likely broke due to patient conditions. 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 product(s). No non-conformity was identified. Based on the given information a deficiency of the nail could not be verified.
 
Event Description
It was reported that on unknown date, patient was implanted with unknown gamma3 short nail for multiple injury and femoral neck fracture. On (b)(6) 2016, surgical treatment again by gamma3 long due to nonunion of the femoral neck fracture. On middle of (b)(6), the patient visited the hospital for pain and it was confirmed that the gamma 3 long was broken. On (b)(6) 2016, it will be treated by unk nail again.
 
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Brand NameUNKNOWN LONG GAMMA3 NAIL
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 Key6149396
MDR Text Key61590634
Report Number0009610622-2016-00603
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
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 02/22/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/06/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNK_KIE
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 Received02/21/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 12/06/2016 Patient Sequence Number: 1
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