MAUDE Adverse Event Report: STRYKER TRAUMA KIEL FEMORAL NAIL, A/R S2 Ø10X420 MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number 1732-1042S

Device Problems Bent (1059); Device Operates Differently Than Expected (2913); Material Twisted/Bent (2981)

Patient Problem No Code Available (3191)

Event Date 08/31/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Doctor reported in a letter sent to stryker the following event : torsion of the nail.The device failed one month and a half after the implantation.As a consequence, the patient underwent a revision surgery.The nail was explanted and replaced.".

Manufacturer Narrative

The reported event of alleged nail bending was confirmed, since x-rays and returned product were in accordance to the allegation.The raw material certificate and the results of translated hardness tests confirmed the required mechanical properties.Dimensional examination revealed no deviations in the relevant undamaged area.The affected item was documented as faultless prior to distribution.During investigation no material, design or manufacturing related issues were found.The received nail was found to have a significant bend located in the approx.The middle.The original geometry in the medio-lateral direction is straight.The received nail had a bend of approx.10°.As there was no bone-to-bone contact ¿ presenting a gap ¿ in this area nearly all forces and bending moments at the fracture site were transferred in lateral direction.Due to the gap the nail had to withstand significant bending loads.The nail is made of stainless steel which has more ductile characteristics / composition.That means that in case high unusual forces are applied to the material, a nail will always get bent before it breaks due to over-bending.In this case the nail had not exceeded the maximum of its tensile strength but applied forces had caused the nail to get plastically deformed.However, the nail design, material and strength were successfully tested and specified during development; the nails are qualified for their specified application under normal conditions.The ifu defines overload as potential adverse effects.The ifu also points out that the surgeon has to warn the patient for potential overload.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.Based on the information given above the cause of the case is attributed to a patient related issue.With available information a deficiency of the devices could not be verified.

Event Description

Doctor reported in a letter sent to stryker the following event : torsion of the nail.The device failed one month and a half after the implantation.As a consequence, the patient underwent a revision surgery.The nail was explanted and replaced".

• Brand Name: FEMORAL NAIL, A/R S2 Ø10X420 MM
• 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: 6922112
• MDR Text Key: 88403009
• Report Number: 0009610622-2017-00318
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K032579
• 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: 04/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/31/2021
• Device Model Number: 1732-1042S
• Device Catalogue Number: 17321042S
• Device Lot Number: K0EF035
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/13/2017
• Initial Date FDA Received: 10/06/2017
• Supplement Dates Manufacturer Received: 03/15/2018
• Supplement Dates FDA Received: 04/09/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/28/2016
• 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: 21 YR
• Patient Weight: 70