MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LONG NAIL KIT R2.0, TI, RIGHT GAMMA3® Ø11X360MM X 125°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 32250360S

Device Problems Break (1069); Fracture (1260)

Patient Problem No Information (3190)

Event Date 05/07/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that gamma3 nail broke.

Event Description

It was reported that gamma3 nail broke.

Manufacturer Narrative

The reported event could be confirmed, since the device was returned for evaluation and matches the reported failure.Device inspection revealed the following: the received device shows significant traces of intense and frequent use.The received nail is completely broken in the webs of the lower proximal lag screw hole.There were relatively more scratches on the inner surface of the proximal part of the hole in the nail than the distal part.Also, appearance of abrupt ridges & abrasion at the terminal of the broken segments indicates that the nail broke from the weaker sections around the hole.On all breakage surfaces, features of a fatigue fracture are visible.Plastic deformation was not found.Scratches only on the proximal part of the hole indicates that during the drilling of the hole inside the bone, the drill contacted the inner surface of the hole.This reduced the fatigue strength of the nail around the hole (confirmed through visual inspection), because of which, the nail broke apart further during the surgery upon application of excessive load than it could sustain.Based on investigation, the root cause was attributed to a user related issue.The failure was caused due to impact caused on the nail during drilling which resulted in reduction of fatigue strength of nail around the hole and eventually application of excessive load during insertion led to breakage.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.Sufficient guidelines, warnings and precautions are pointed out in the operative technique guide: ¿caution: pre-drilling offers a possibility to open the lateral cortex for the k-wire entry.Pre-drilling helps to prevent a possible slipping of the k-wire on the cortex and may avoid deflection within the femoral head.This helps to perform the lag screw reaming without nail contact.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.¿ no indications of material, manufacturing or design related problems were found during the investigation.If any further information is provided, the complaint report will be updated.

• Brand Name: LONG NAIL KIT R2.0, TI, RIGHT GAMMA3® Ø11X360MM 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: 8651312
• MDR Text Key: 146417192
• Report Number: 0009610622-2019-00393
• 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: health professional
• Type of Report: Initial,Followup
• Report Date: 07/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/31/2023
• Device Catalogue Number: 32250360S
• Device Lot Number: K034868
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2019
• Date Manufacturer Received: 06/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention