MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LONG NAIL KIT R1.5, TI, LEFT GAMMA3® Ø11X380MM X 130°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 35301380S

Device Problem Break (1069)

Patient Problem Failure of Implant (1924)

Event Date 11/10/2016

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The broke gamma 3 long nail was extracted from the patient.The dr.Then proceeded with the case by using a gamma 3 short nail to replace the removed component.

Manufacturer Narrative

The evaluation revealed the broken nail to be the primary product.No deviations were found during review of the manufacturing and inspection documents (dhr).The nail was documented as faultless prior to distribution.Correct dimension on the returned nail were confirmed in the undamaged areas.The evaluation revealed that the nail broke most likely in a fatigue fracture after a period of approx.4, 5 months of implantation.According to found damages the fatigue fracture had its origination in the anterior web at lateral.In this area significant material damage had weekend the web caused by misaligned drilling with the step drill; which presents an unintentional use error.A remarkable material damage at superior in the edge of the proximal drill hole was proven having initially been caused by drilling under a wrong angulation.It could not be determined whether the angulation had been corrected to the suitable angulation.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.Potential causes for events resp.Warnings are listed in the labelling.In this case the nail broke in an area where the material had been weakened significantly by intra-operative misaligned drilling which was considered as user related.As medical records were not provided the course of bone could not be determined.A medical review was not possible.Based on the above the nail breakage was not linked to a deficiency of the device but was mainly user related, 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.The event was not linked to a deficiency of the device.

Event Description

The broke gamma 3 long nail was extracted from the patient.The dr.Then proceeded with the case by using a gamma 3 short nail to replace the removed component.

• Brand Name: LONG NAIL KIT R1.5, TI, LEFT GAMMA3® Ø11X380MM X 130°
• 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: 6149353
• MDR Text Key: 61589581
• Report Number: 0009610622-2016-00602
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 03/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/30/2019
• Device Catalogue Number: 35301380S
• Device Lot Number: K07387C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/24/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/02/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2014
• 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