MAUDE Adverse Event Report: STRYKER TRAUMA KIEL FEMORAL NAIL, A/R S2 Ø11X440 MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 17321144S

Device Problems Difficult to Remove (1528); Sticking (1597)

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

Event Date 08/04/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported by the pharmacist within (b)(6) hospital, that during a surgery, the s2 nail remained stuck in the holder and can not be removed.

Manufacturer Narrative

The evaluation revealed all products to be primary product.No deviations were found during review of the manufacturing and inspection documents (dhr).The items returned were documented as faultless prior to distribution.The nail had to be removed because already engaged to the nail handle/nails holding screw and it was not possible to release the nail during surgery.As the nhs had been in use for approx.10 years and the nail handle for approx.2 years, we pre-suppose that the items had fulfilled their tasks in former surgeries as intended.Dimensional examination revealed no deviations in the relevant undamaged areas.A hardness test according to rockwell revealed the hardness of the materials being within specified parameters.During investigation no material, design or manufacturing related issues were found.The nhs stuck within the nail handle, so that the nail was not detachable from the handle.In order to detach the nail it was necessary to treat the nail handle and the nail holding screw mechanically; which caused additional damages not related to the cause of the event.After disassembling significant abraded material/fretting marks were visible, running in circumferential direction over the plane surfaces of both nail adapter and nail holding screw.Fretting marks are a rare but known reaction.During screwing into the nail the nhs gets in contact with the metal nail adapter and friction could occur due to too high torque forces (user related).In combination with small tolerances it is possible that cold welding occurs.The found fretting marks indicate that most likely cold welding has occurred in the actual case.The appearance of the damage indicated that the devices got jammed by ¿cold welding¿ due to friction corrosion being caused by high surface pressure.It can be supposed that during surgery the nhs had been screwed into the nail with excessive force.Possibly, in this case the torsional force had not been applied constantly to the nhs but with a quick movement with which would explain the relatively high loosening torque whilst attempting to disassemble the items during surgery.The hexagon had most likely become worn during the attempts of detachment.As the nail holding screw had been in use for a longer time [manufactured in 2007] before the alleged event was reported we pre-suppose that it had fulfilled its tasks in former surgeries as intended.It could not be excluded that the device was pre-damaged after such a long time.However, the use of a, not realized, pre-damaged will inevitably cause damages on the mating counterpart.Review of complaint history, capa databases and risk analysis did not identify any discrepancies.There were no open actions in place related to the reported event for the subject product(s).No non-conformity was identified.Based on the above, the root cause of the reported event was not device related, but was most likely linked to an inadequate handling by the user.

Event Description

It was reported by the pharmacist within (b)(6), that during a surgery, the s2 nail remained stuck in the holder and can not be removed.

• Brand Name: FEMORAL NAIL, A/R S2 Ø11X440 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: 6828761
• MDR Text Key: 84091983
• Report Number: 0009610622-2017-00276
• 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: consumer
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 12/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 17321144S
• Device Lot Number: K0AC98E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/30/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2015
• 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): Other