MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LONG NAIL KIT R1.5, TI, RIGHT GAMMA3® Ø13X360MM X 125°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 34253360S

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/24/2018

Event Type  Injury  

Manufacturer Narrative

It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Initial reporter sent the device for pathology culture test.

Event Description

It was reported that nail failed at the intersection of the lag screw after 3 years of use.Pt had bone cancer and didn't grow any bone to support the implant.No surgical delay, no adverse consequences.

Manufacturer Narrative

The reported event that long nail kit r1.5, ti, right gamma3® ø13x360mm x 125° was alleged of issue k-170 (implant breakage - nail) could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.The device inspection was not possible as the product was not returned for investigation.The device history record could not be reviewed because the affected device was not returned and the lot number was not communicated.As per the received event details the failure of nail was caused ¿after 3 years of use¿ and that the ¿pt had bone cancer and didnt grow any bone to support the implant¿.Thus this is clearly a case of non-union and the root cause can be attributed to a patient related factor.A review of the labeling did not indicate any abnormalities.The instructions for use instructs user that ¿these devices are intended only to assist healing and are not intended to replace normal bone structures.¿ the contraindications clearly states below factors ¿¿ bone stock compromised by disease, infection or prior implantation that can not provide adequate support and/or fixation of the devices.Other medical or surgical conditions which would preclude the potential benefit of surgery.¿ the adverse consequences are also mentioned as below ¿ ¿in many instances, adverse results may be clinically related rather than device related.The following are the most frequent adverse effects involving the use of internal fracture fixation devices: delayed union or non-union of the fracture site.Conditions attributable to non-union, osteoporosis, osteomalicia, diabetes, inhibited revascularization and poor bone formation can cause loosening, bending, cracking, fracture of the device or premature loss of rigid fixation with the bone.¿ if device is returned or any further information is provided, the investigation report will be reassessed.

Event Description

It was reported that nail failed at the intersection of the lag screw after 3 years of use.Pt had bone cancer and didnt grow any bone to support the implant.No surgical delay, no adverse consequences.

• Brand Name: LONG NAIL KIT R1.5, TI, RIGHT GAMMA3® Ø13X360MM X 125°
• 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: 7452309
• MDR Text Key: 106246786
• Report Number: 0009610622-2018-00191
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• PMA/PMN Number: K034002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 06/27/2018

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 Catalogue Number: 34253360S
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/26/2018
• Initial Date FDA Received: 04/23/2018
• Supplement Dates Manufacturer Received: 05/31/2018
• Supplement Dates FDA Received: 06/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention