MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X45 MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 18965045S

Device Problems Break (1069); Failure to Osseointegrate (1863)

Patient Problem Inadequate Osseointegration (2646)

Event Date 11/09/2015

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The sales rep has reported on behalf of the customer that a patient has undergone revision surgery on a t2 ankle arthrodesis nail, due to alleged lack of fusion.The sales rep has reported that when the patient was opened up it was noticed that two screws had snapped.The surgery was completed successfully by inserting two new screws and a the planned longer nail.

Manufacturer Narrative

The two broken locking screws were classified as primary product during investigation.No deviations were found during review of the manufacturing and inspection documents (dhr).The locking screws returned were documented as faultless prior to distribution.During investigation no material, design or manufacturing related issues were found.The breakage surfaces of both screws are smooth and show lines of rest; both screws broke due to a fatigue fracture.The windings of the screw threads are partly deformed / abraded and destroyed, most likely due to heavy postoperatively contact with the nail hole rims, combined with nail hole rim contact during screw implantation.The screws broke due to a postoperatively overload, the implants were loaded several times with too high bending forces.Due to this the screws cracked and broke step by step till they got completely broken after approx.Eight months.The patient¿s height and weight were not provided, obesity cannot be excluded.The customer reported that the nail was exchanged to a longer nail due to ¿lack of fusion¿ and to ¿prevent the nail migrating medically in the tibia as it had done with 150 nail.¿ a lack of fusion could not be confirmed or denied; a fusion or non-fusion could not be determined based on the provided x-ray.The position of the inserted compression screw and the contact-marks on the partly threaded screw indicates that the tibia-talar-compression was performed; therefore it is most likely that the compression of the tibia-talar-joint was successfully done.If the talar-calcaneal-compression was also successfully done could not be determined due to missing information, but the fact that the screws within the calcaneal bone got broken indicates that most likely the joint was still free or partly moveable over the whole implantation time of approx.8 months.An inadequate compression of this joint most likely happened.A medically migration was not visible on the provided x-ray; therefore the migration could not be confirmed or denied.The ifu includes several adverse effects (obesity, intra-operatively implant damages, post-operatively loads, etc.) that can lead to implant failures like screw breakages.The successfully joint compression of both joints is described in detail in the operative technique.As a secondary issue it was found that the distal nail holes were drill marked; the most distal hole was completely missed and the outer nail surface was damaged by the drill on the medial side.It is likely that the target device was pre-damaged and / or the nail holding screw was not tightened to the nail and / or bending forces were applied to the drill / target device during drilling.The ifu and operative technique includes that every instrument shall be checked prior to every surgery regarding its functionality.Based on the investigation and all given information the screw breakages are not manufacturer related; they broke due to postoperative overloading (patient related) combined with damages during implantation and most likely with an inadequate compressed subtalar joint (user related).No non-conformity identified.

Event Description

The sales rep has reported on behalf of the customer that a patient has undergone revision surgery on a t2 ankle arthrodesis nail, due to alleged lack of fusion.The sales rep has reported that when the patient was opened up it was noticed that two screws had snapped.The surgery was completed successfully by inserting two new screws and the planned longer nail.

• Brand Name: LOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X45 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: 5254959
• MDR Text Key: 32312437
• Report Number: 0009610622-2015-00565
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: GB
• PMA/PMN Number: K032244
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/09/2015

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: 09/30/2019
• Device Catalogue Number: 18965045S
• Device Lot Number: K025CBE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/09/2015
• Initial Date FDA Received: 11/30/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/08/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/01/2014
• 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: 65 YR