MAUDE Adverse Event Report: STRYKER TRAUMA KIEL TROCHANTERIC NAIL KIT, STST GAMMA3 11X180MM X 130; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 41301180S

Device Problems Positioning Failure (1158); Difficult or Delayed Separation (4044)

Patient Problem Blood Loss (2597)

Event Date 03/05/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Sales rep reported that : "a 130° gamma3 trochanteric nail was placed on a patient as part of a preventive nailing of the right femoral neck, a secondary lesion.The cervical screw got stuck in the nail, making it impossible to screw it in.The nail was removed (with difficulty due to the absence of extraction material in the ancillary instruments used) and the cervical screw couldn't pass through the nail while it passed through the other nail in place." nail replaced.Surgery delay: yes, time extended by significant amount of time (not aware how long) significant patient bleeding.

Manufacturer Narrative

Correction: refer to d10, h3 the reported event that trochanteric nail kit, stst gamma3® ø11x180mm x 130° was alleged of issue ¿implant - insertion impaired¿ could not be confirmed, since the device was not returned, and no other evidences were provided.A device inspection was not possible since the affected device was not returned, and no other evidences were provided for investigation.Due to the current covid-19 pandemic, it was not possible to receive the product for evaluation.The investigation will be reassessed as soon as the product is received.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 manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.However, based on risk management files one of the probable causes could be: handling failure (e.G.Length is measured incorrectly, position of drill guide sleeve is incorrect, misdrilling) if any additional information is provided, the investigation will be reassessed.Device return is restricted to due covid-19 pandemic.

Event Description

Sales rep reported that : "a 130° gamma3 trochanteric nail was placed on a patient as part of a preventive nailing of the right femoral neck, a secondary lesion.The cervical screw got stuck in the nail, making it impossible to screw it in.The nail was removed (with difficulty due to the absence of extraction material in the ancillary instruments used) and the cervical screw couldn't pass through the nail while it passed through the other nail in place." nail replaced.Surgery delay : yes, time extended by significant amount of time (not aware how long) significant patient bleeding.

Manufacturer Narrative

Correction: refer to h3 (reason code).The reported event that trochanteric nail kit, stst gamma3® ø11x180mm x 130° was alleged of issue ¿implant - insertion impaired¿ could not be confirmed, since the device was not returned, and no other evidences were provided.A device inspection was not possible since the affected device was not returned, and no other evidences were provided for investigation.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 manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.However, based on risk management files one of the probable causes could be: handling failure (e.G.Length is measured incorrectly, position of drill guide sleeve is incorrect, mis-drilling).If any additional information is provided, the investigation will be reassessed.H3 other text : device disposition is unknown.

Event Description

Sales rep reported that : "a 130° gamma3 trochanteric nail was placed on a patient as part of a preventive nailing of the right femoral neck, a secondary lesion.The cervical screw got stuck in the nail, making it impossible to screw it in.The nail was removed (with difficulty due to the absence of extraction material in the ancillary instruments used) and the cervical screw couldn't pass through the nail while it passed through the other nail in place." nail replaced.Surgery delay : yes, time extended by significant amount of time (not aware how long) significant patient bleeding.

• Brand Name: TROCHANTERIC NAIL KIT, STST GAMMA3 11X180MM X 130
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; DE D-24232
• MDR Report Key: 9908201
• MDR Text Key: 193101725
• Report Number: 0009610622-2020-00137
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 08/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 41301180S
• Device Lot Number: KU115031
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 63 YR
• Patient Weight: 84