MAUDE Adverse Event Report: STRYKER TRAUMA KIEL TROCHANTERIC NAIL KIT, TI GAMMA3® Ø11X180MM X 125°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 31251180S

Device Problems Break (1069); Fracture (1260)

Patient Problems Fall (1848); Bone Fracture(s) (1870); Failure of Implant (1924)

Event Date 10/01/2016

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

Nail broke after patient fall out of the bed.

Manufacturer Narrative

Evaluation revealed the trochanteric nail kit, ti gamma3® ø11x180mm x 125° to be the primary product.The lag screw, ti gamma3® ø10.5x100mm was considered as a concomitant product as it did not contribute to the event reported.Deficiency in material or manufacturing was not found.The affected item was documented as faultless prior to distribution.Thus, we excluded deviations in material and manufacturing.In the case presented a patient had been treated with a trochanteric nail kit on (b)(6) 2016 due to a per-trochanteric fracture of her left femur, which had occurred after a fall in the garden.On (b)(6) 2016 the patient had to be revised as the gamma3 nail was found to be broken.According to information received, the patient fell out of her bed.She fell on her left hip.She was revised by a long gamma3 nail.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.This state must be achieved within a medically recognized period (confirmed by scientific analysis about 6 months) in such way, that the bone strength allows significantly increasing discharge of the time-fixed implant material.In case that such a situation does not occur, exceeding of the fatigue strength is to be expected and thus quite predictable complications.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 stressed by too high load application e.G.(but not limited to) exceeding weight bearing or other stresses.In the given case the patient had experienced a fall on her left hip when falling out of the bed leading to the breakage of the nail.Traumatic overloads and postoperatively loads are adverse effects that can lead to implant breakages and are listed in the ifu and operative technique.Based on the above the nail breakage was not linked to a deficiency of the device, but was rather patient related (traumatic overload as a result from the fall).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 product.No non-conformity was identified.

Event Description

Nail broke after patient fall out of the bed.

• Brand Name: TROCHANTERIC NAIL KIT, TI GAMMA3® Ø11X180MM 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: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6555584
• MDR Text Key: 74772216
• Report Number: 0009610622-2017-00142
• 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: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/31/2021
• Device Catalogue Number: 31251180S
• Device Lot Number: K067D51
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/22/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/15/2016
• 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: 65 YR