MAUDE Adverse Event Report: STRYKER TRAUMA KIEL TROCHANTERIC NAIL KIT, TI GAMMA3® Ø11X200MM X 125°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 31251200S

Device Problem Break (1069)

Patient Problem Pain (1994)

Event Date 01/23/2015

Event Type  Injury  

Manufacturer Narrative

Once the investigation has been completed any additional information will be reported in a supplemental report.

Event Description

During rehab the patient got pain during walking.X-ray showed a broken nail.

Manufacturer Narrative

Device was not returned.No deviations were found during review of the manufacturing and inspection documents (dhr).The nail was documented as faultless prior to distribution.The evaluation revealed that the nail broke after a period of approx.5 weeks of implantation.Nail breakage in general has been experienced; it does not present an unanticipated event in itself.Depending on the load application, also, depending on the patient¿s post implant behaviour, on the suitable anatomical reduction, on the kind of bone breakage and depending on the course of bone healing and other factors a nail breakage can rather be classified as anticipated ¿ specifically if one or more contributing issues concurrence with each other.A successful treatment requires sufficient bone healing during the implantation period.A nail will be subject of a fatigue fracture if the stresses on the implant are too high or not considerably reduced during the period of implantation.The affected implant is designed to withstand the normal loads during the implantation period, i.E.The implant must neither be exposed to peak loads nor to continuous stresses.Another prerequisite for a successful supply is undisturbed, normal bone healing.In case that such a situation does not occur, exceeding of the fatigue strength is to be expected and thus quite predictable complications.Due to the missing products it could not be determined in what manner the nail had broken.As the implant was not available it could not be determined whether the nail had been damaged intra-operatively.Since neither x-ray documentation nor surgery reports were available, a medical review was not possible.It could not be determined, whether the use of the nail neither had the correct indication nor could be determined if the implant had been placed according to the anatomical requirements.Based on the limited information a deficiency of the nail in question was not verified.With the information given an exact root cause could not be determined.The file will be closed formally.In case relevant information resp.The parts become available we reserve the right to update the investigation and to change the root cause.Review of complaint history, capa databases and risk analysis did not identify any conspicuity.The review of the risk assessment for the failure mode indicated the issue was addressed adequately.There are no actions in place related to the reported event for the subject products.No non-conformity was identified.With available information a deficiency of the device could not be verified.

Event Description

During rehab the patient got pain during walking.X-ray showed a broken nail.

• Brand Name: TROCHANTERIC NAIL KIT, TI GAMMA3® Ø11X200MM X 125°
• Type of Device: ROD, 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: rose haas ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6190397
• MDR Text Key: 62858587
• Report Number: 0009610622-2016-00631
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• PMA/PMN Number: K034002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/30/2019
• Device Catalogue Number: 31251200S
• Device Lot Number: K0F4061
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/14/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR