MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LONG NAIL KIT R1.5, TI, LEFT GAMMA3 11X420MM X 125; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number 3525-1420S

Device Problem Fracture (1260)

Patient Problems Failure of Implant (1924); Injury (2348); Non-union Bone Fracture (2369); Implant Pain (4561)

Event Date 06/29/2020

Event Type  Injury  

Manufacturer Narrative

Upon completion of investigation, additional information will be provided in a supplemental report.

Event Description

The customer reported that the gamma nail broke requiring revision.Mobilisation instructions: mobilisation as tolerated.Patient mobilised well with stick after being discharged from primary op.Uses stick sometimes when outside but does not use stick indoors.No trauma.

Manufacturer Narrative

The reported event could be confirmed, since the device was returned for evaluation and matches the alleged failure mode.Device inspection revealed the following: the received nail is completely broken in the webs of the proximal lag screw hole.The appearance of the breakage surface of the anterior web suggests that the nail breakage had its origin in this area.Severe material erosion is evident around the anterior web.The fracture pattern resembles a fatigue fracture, evident by very marginal appearance of lines of rest/ waves.Starting from that region with an incipient crack at the lateral edge, the breakage progressed through the cross section.As a result of which the posterior web broke in a much quicker way with increased loading as result of nonunion, signs of which are visible along the curved edge of the posterior web.Severe drill marks were found at the lateral entrance of the proximal through hole at the anterior web; they progress through the bore towards medial.The drill marks were generated by a deviated lag screw step drill which most likely had created the starting point of the fracture (notching effect) at the lateral edge of the anterior web.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.A clinical statement was requested for the evaluation of the provided medical data.The following statements were provided: ¿we have a complex subtrochanteric fracture with dislocation of the lesser trochanter-fragment.That fragment was left dislocated.The several cerclages, very long nail.The alignment is not bad in the march postoperative x-rays.As lauenstein-view images are missing the situation can only be assessed from the ap-view.Via self dynamization due to non-union the distal screws broke, however, this did not result in compression and healing of the bone and finally this led to failure.From the x-rays and from the information on the patient there can be no factor identified leading to the breakage of the nail.The age adapted bmi of the patient is fine and i would not regard this as a relevant factor.The main contributing factor is the fracture pattern.¿ based on the above investigation, it is evident that the nail broke due to a combination of factors including a non-union, a complex fracture pattern, and finally the mis-drilling but predominantly the root cause of the failure can be attributed to a complex fracture pattern which is a patient related factor.Initially a non-union lead to self-dynamization of the distal screws which broke first, consequently the increased load on the nail and initial damage during drilling lead to the breakage of the nail as well.The op-tech provides a warning to the user: ¿warning: in the event the nail is damaged during lag screw reaming, the fatigue strength of the implant may be reduced, which may cause nail to fracture.¿ if any further information is provided, the complaint report will be updated.

Event Description

The customer reported that the gamma nail broke requiring revision.Mobilization instructions: mobilization as tolerated.Patient mobilized well with stick after being discharged from primary op.Uses stick sometimes when outside but does not use stick indoors.No trauma.

• Brand Name: LONG NAIL KIT R1.5, TI, LEFT GAMMA3 11X420MM 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; GM D-24232
• MDR Report Key: 10310995
• MDR Text Key: 199986418
• Report Number: 0009610622-2020-00369
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 07613252274308
• UDI-Public: 07613252274308
• Combination Product (y/n): N
• PMA/PMN Number: K034002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 10/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/30/2018
• Device Model Number: 3525-1420S
• Device Catalogue Number: 35251420S
• Device Lot Number: K07E7A9
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2020
• Date Manufacturer Received: 09/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR
• Patient Weight: 79