MAUDE Adverse Event Report: STRYKER TRAUMA KIEL NAIL ADAPTER S2; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 18068001

Device Problems Break (1069); Difficult to Insert (1316)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 12/23/2015

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The surgeon reported the following event:"it was not possible to screw the tibial nail at the proximal area.The drill broke inside the patient.The nail holding must be twisted since i broke the drill by screwing at the proximal area.Little surgery delay (no time precised).Decided not to retrieve the drill inside the patient, it will stay in there.I will remove it when i remove the nail in 1 or 2 year.This will lead at that time to a more important surgery time and an additional invasive cortectomy procedure for the patient.".

Manufacturer Narrative

Review of the manufacturing and inspection records revealed no discrepancies.The item returned was documented as faultless prior to distribution.During investigation no material, design or manufacturing related issues were found.The returned nail adapter was fully functional.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 matter was addressed adequately.There are no actions in place related to the reported event for the subject product.No non-conformity was identified.According to received information the drill broke during the drilling process.The event description described the situation ¿it was not possible to screw the tibial nail at the proximal area.The nail holding must be twisted since i broke the drill by screwing at the proximal area.¿ the connection ¿ seated by a mating pegs / slots - between nail and nail adapter is secured by a nail holding screw.According to above statement it could be suggested that the nail holding screw could not be engaged correctly into the nail¿s thread.This is usually caused when the pegs and slots are not correctly engaged ¿ e.G.May have become loose during the insertion procedure.The loosening was obviously observed after starting drilling resulting in the attempt to ¿re-tighten¿ the construct with the drill still engaged in the nail.Consequently, due to axial loading (screwing) and rigid connection (drill in nail¿s drill hole) the drill broke inside the patient.The labelling points out to ¿repeatedly check that the connections between the instruments or between implants and instruments required for the precise positioning and fixing are secure.¿ however it cannot be excluded that the drill had been pre-damaged during former surgeries, but the damage should then have been detected during inspection prior to surgery and another device would have been used.The labelling points out that damage have to be avoided.Based on the above facts it was concluded that the root cause was not related to a deficiency of the device, because fully functional, but was rather linked to an inadequate handling by the user.In case relevant information becomes available we reserve the right to update the investigation and to change the root cause.The event was not caused by a deficiency of the device.

Event Description

The surgeon reported the following event:"it was not possible to screw the tibial nail at the proximal area.The drill broke inside the patient.The nail holding must be twisted since i broke the drill by screwing at the proximal area.Little surgery delay (no time precised).Decided not to retrieve the drill inside the patient, it will stay in there.I will remove it when i remove the nail in 1 or 2 year.This will lead at that time to a more important surgery time and an additional invasive cortectomy procedure for the patient.".

• Brand Name: NAIL ADAPTER S2
• 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: 5387214
• MDR Text Key: 36710161
• Report Number: 0009610622-2016-00026
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K113409
• 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: 12/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 18068001
• Device Lot Number: KHI130093
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/07/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/01/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other