MAUDE Adverse Event Report: STRYKER TRAUMA KIEL FEMORAL NAIL, A/R T2 FEMUR Ø15X400 MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 18251540S

Device Problems Tear, Rip or Hole in Device Packaging (2385); Device Disinfection Or Sterilization Issue (2909)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/28/2018

Event Type  malfunction  

Manufacturer Narrative

Once the investigation has been completed any additional information will be reported in a supplemental report.The package in question is available.

Event Description

The sterile packed t2 femur nail was unwrapped, the undamaged cardboard box was opened and the nail given to the sterile nurse.Afterwards it was recognized that the inner blister had a crac that ran for about 25 cm along the side of the blister and also across to the other side.The nail was considered to be unsterile.The nail was removed from the sterile field, the drapes that were touched were exchanged and the nail cleaned and sterilized.The nail was then implanted as no other nail of this dimension was available in (b)(6).The nail was removed from the sterile field and put into a washing machine for cleaning, afterwards packed separately and then put into the sterilisation.Material that was touched by the potentially contaminated nail was exchanged for new.Surgical delay of 210 min.Not longer.No other consequences reported.As the surgery was only finished on (b)(6) 2018 potential problems resulting from the long surgery time could not be detected at this time.

Manufacturer Narrative

Product inquiry states the femoral nail, a/r t2 femur ø15x400 mm packaging to be the subject product.No associated products were reported.A review of the dhr revealed no deviations, in particular in the packaging process, and the device was documented as faultless prior to distribution.A deviation due to incorrect packaging of the device into the cardboard box could be excluded as the found damage shows significant traces of an impact or contact by another object.No discrepancies were reported during incoming inspection at distribution site.Thus, we exclude that the damage was generated during the packaging process or during shipment from stryker kiel to the distribution site.Based on the information given an exact root cause could not be determined but as known from previous cases it is most likely transport damage due to rough handling, which occurred during shipping from the distribution site to the hospital or at the hospital itself, which is beyond the manufacturer¿s control.Furthermore, ifu l22000007 instructs among others: ¿pre-operative: ensure that all components needed for the operation are available in the operation theatre.Inspection is recommended prior to surgery to determine if implants have been damaged during storage.¿ however, the originator of the damage found cannot be determined in this case.No further complaint regarding this lot involving a patient harm for the reported failure has been reported up to now.

Event Description

The sterile packed t2 femur nail was unwrapped, the undamaged cardboard box was opened and the nail given to the sterile nurse.Afterwards it was recognized that the inner blister had a crack that ran for about 25 cm along the side of the blister and also across to the other side.The nail was considered to be unsterile.The nail was removed from the sterile field, the drapes that were touched were exchanged and the nail cleaned and sterilized.The nail was then implanted as no other nail of this dimension was available in (b)(6).The nail was removed from the sterile field and put into a washing machine for cleaning, afterwards packed separately and then put into the sterilisation.Material that was touched by the potentially contaminated nail was exchanged for new.Surgical delay of 210 min.Not longer.No other consequences reported.As the surgery was only finished on (b)(6) 2018 potential problems resulting from the long surgery time could not be detected at this time.

• Brand Name: FEMORAL NAIL, A/R T2 FEMUR Ø15X400 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
• MDR Report Key: 7345572
• MDR Text Key: 102877094
• Report Number: 0009610622-2018-00075
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• PMA/PMN Number: K010801
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 07/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/31/2022
• Device Catalogue Number: 18251540S
• Device Lot Number: K034D43
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/14/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other