MAUDE Adverse Event Report: STRYKER GMBH ONE-STEP INSERTION WRENCH OMEGA; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number 704002

Device Problems Break (1069); Disconnection (1171); Naturally Worn (2988)

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

Event Date 08/04/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The registrar was performing a procedure using the omega chs and the first few steps of the procedure progressed as expected.The guide wire was inserted and a 100mm lag screw measurement reading taken.Reaming was undertaken while the 100mm lag screw and 135 degree 3 hole plate were opened.The plate and the lag screw were then assembled onto the one-step-insertion device as per the operative technique by both the scrub and the registrar.The registrar proceeded to insert the lag screw and it was advanced the majority of the way.At this point the surgeon and the registrar reported that the t-handle was being turned but the lag screw was no longer turning or advancing.X-ray imaging showed small fragments of broken metal and a disconnection of the lag screw with the one-step-insertion device.The customer reported that an attempt to reconnect the device with the lag screw failed.An attempt to insert the plate over the lag screw also failed.At this point the consultant scrubbed and took a lead in the procedure.The lag screw was removed using the lag screw inserter.Another lag screw was opened and inserted using the lag screw insertion assembly.The plate was impacted over the top and the 4.5mm cortical screws were inserted.The customer reported that upon inspection of the removed lag screw it was visible that the two prongs on the head of the screw had completely worn away.Before the second lag screw was inserted the patient's wound was fully debrided and all the metal fragments removed.There was no reported injury to the patient.Length of surgery time for the patient was increased beyond that expected.Future procedures will follow the two step technique.

Manufacturer Narrative

The reported incident that the one-step insertion wrench omega failed to connect with the rest of the one-step assembly system (s-31 / no fitting) could not be confirmed, since the device was returned for evaluation and it was verified that it is fully functional and manufactured according to the specifications.The ¿one-step insertion wrench omega¿ has a slightly scratched surface.The cannulation looks clean, while the lower part of the wrench, where the pegs are located, looks in a very good condition without any scratches or deformations.The one-step assembly, with the use of all the received devices, was performed, and it was identified that the lag screw cannot be assembled with the rest of the system, because its deformed surface does not allow the bolt to be inserted within the cannulation of the screw.However, the ¿one-step insertion wrench omega¿ can be perfectly assembled with the rest of the system without causing any malfunctions.The one-step assembly, with the use of all the received devices but in combination with a new lag screw (with the same catalog no), was performed, and it was identified that the system can be assembled without any malfunctions and can perform according to the specifications.Most likely during usage of the whole one-step assembly system, the lag screw was not properly assembled with the rest of the devices and this caused the disconnection during the insertion process.This matches with the reported event that ¿the t-handle was being turned but the lag screw was no longer turning, and the x-ray imaging showed small fragments of broken metal and a disconnection of the lag screw with the one-step-insertion device¿.Normally the notches of the lag screw are assembled with the pegs of the wrench, and the bolt is used to keep them together.If the lag screw was not properly assembled or tightly screwed with these devices, then potential play could be created, which could definitely compromise the contact surface and lead to a breakage/deformation of the screw.On top of that, due to the transmitted torque from the handle to the rest of the devices, in combination with a wrong assembly, a plastic deformation could definitely be generated.This is evident, since the deformed surface of the screw has signs of rotation that could easily be created if during rotation of the lag screw, the near-by device was not correctly attached and destroyed the surface of the screw as it came in contact with it.For that reason, please pay attention to what is clearly written in the op.Tech.: "ensure that you are familiar with the intended uses, indications/contraindications, compatibility and correct handling of the implant.Please remember that product systems may be subject to alterations that affect the compatibility of the implant with other implants or with instruments.Implants which consist of several components must only be used in the prescribed combination." if the devices were not used in the right way and order, a disassembly could have been created leading to a deformed surface as the one reported.Furthermore, please be aware of what is indicated in the ifu: ¿inspection is recommended prior to surgery to determine if implants have been damaged during storage.Instruments should be examined for wear or damage prior to surgery.Before the surgical procedure, ensure that all components prepared for the procedure function correctly with each other, while during the procedure, repeatedly check that the connections between the instruments or between implants and instruments required for the precise positioning and fixing are secure.¿ it was also reported that the customer removed the lag screw with the ¿use of the lag screw inserter, which is comprised of the lag screw adapter assembly, lag screw inserter and lag screw inserter sleeve.¿ however, in the op.Tech it is clearly written that if the need for hardware removal arises, ¿the lag screw is extracted after removal of the hip plate through use of the large elastosil t-handle connected to the lag screw inserter and the connecting bolt.¿ using a wrong system to remove the lag screw can definitely lead to a deformed surface as the one received.Therefore, once again, please pay attention to the op.Tech.: "ensure that you are familiar with the intended uses, indications/contraindications, compatibility and correct handling of the implant.Please remember that product systems may be subject to alterations that affect the compatibility of the implant with other implants or with instruments.Implants which consist of several components must only be used in the prescribed combination." a deviation from the instructions for use, can lead to physical changes (deformations, scratches, damages) of the material which may compromise the integrity of the design and/or materials leading to diminished safety, performance and/or compliance with relevant specifications.Since the screw was extracted in a wrong way it is evident that its surface was completely deformed, and as a result a proper inspection cannot be performed.Last but not least, for cannulated devices, the users should always ¿ensure that bone debris does not accumulate in the cannulation of the instrument.¿ therefore appropriate cleaning and inspection should be performed in order to avoid any of the mentioned situations.According to the cleaning and sterilization guide, ¿the instruments which are supplied in a non-sterile condition must be subjected to an appropriate cleaning and sterilization process before use.Pay particular attention to cannulations and blind holes.Generally un-magnified visual inspection under good light conditions is sufficient.Particular attention should be paid to recessed features (holes, cannulations).Based on the above mentioned observations, the root cause was attributed to a user related issue.Most likely a not proper assembly of the devices, and a mishandling during removal, led to a deformation of the screws` surface.A review of the device history for the reported ¿one-step insertion wrench omega¿ did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If any further information is provided, the investigation report will be updated.

Event Description

The registrar was performing a procedure using the omega chs and the first few steps of the procedure progressed as expected.The guide wire was inserted and a 100mm lag screw measurement reading taken.Reaming was undertaken while the 100mm lag screw and 135 degree 3 hole plate were opened.The plate and the lag screw were then assembled onto the one-step-insertion device as per the operative technique by both the scrub and the registrar.The registrar proceeded to insert the lag screw and it was advanced the majority of the way.At this point the surgeon and the registrar reported that the t-handle was being turned but the lag screw was no longer turning or advancing.X-ray imaging showed small fragments of broken metal and a disconnection of the lag screw with the one-step-insertion device.The customer reported that an attempt to reconnect the device with the lag screw failed.An attempt to insert the plate over the lag screw also failed.At this point the consultant scrubbed and took a lead in the procedure.The lag screw was removed using the lag screw inserter.Another lag screw was opened and inserted using the lag screw insertion assembly.The plate was impacted over the top and the 4.5mm cortical screws were inserted.The customer reported that upon inspection of the removed lag screw it was visible that the two prongs on the head of the screw had completely worn away.Before the second lag screw was inserted the patient's wound was fully debrided and all the metal fragments removed.There was no reported injury to the patient.Length of surgery time for the patient was increased beyond that expected.Future procedures will follow the two step technique.

• Brand Name: ONE-STEP INSERTION WRENCH OMEGA
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• Manufacturer (Section G): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• Manufacturer Contact: rose haas ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5904061
• MDR Text Key: 54045071
• Report Number: 0008031020-2016-00413
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Reporter Country Code: GB
• 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: 08/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 704002
• Device Lot Number: 02924J
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/11/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/15/2015
• 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