MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LONG NAIL KIT R2.0, TI, RIGHT GAMMA3® Ø11X320MM X 125°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	32250320S
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/04/2018
Type of Reportable Event	Serious Injury
Additional 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.Device disposition is unknown.
Event or Problem Description
It was reported by the end user that 3 weeks after the medical procedure, while the patient was walking, she heard a 'crack' noise from her hip.At the hospital they found that the nail was broken.The nail was replaced on another surgery.
Event or Problem Description
It was reported by the end user that 3 weeks after the medical procedure, while the patient was walking, she heard a 'crack' noise from her hip.At the hospital they found that the nail was broken.The nail was replaced on another surgery.
Additional Manufacturer Narrative
Concomitant medical products the reported event that long nail kit r2.0, ti, right gamma3® ø11x320mm x 125° was alleged of k-170 (implant breakage - nail) could be confirmed, since the device returned for evaluation matches the alleged failure mode.Visual inspection revealed that the evaluation revealed that the nail broke in a fatigue fracture after a period of more than 8 months of implantation.According to the inspection significant material damage had weekend the web caused by misaligned drilling with the step drill; which presents an unintentional use error.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.Thus, based on the investigation the root cause can most likely be attributed to ¿user related¿, as the nail was considerably pre-damaged intra-operatively most likely due to misaligned drilling with the step drill; which presents an unintentional use error.If any further information is provided, the investigation report will be updated.

• Brand Name: LONG NAIL KIT R2.0, TI, RIGHT GAMMA3® Ø11X320MM X 125°
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32
• MDR Report Key: 7593473
• Report Number: 0009610622-2018-00239
• Device Sequence Number: 1317292
• Product Code: HSB
• UDI-Device Identifier: 07613153312734
• UDI-Public: 07613153312734
• Combination Product (Y/N): N
• PMA/510(K) Number: K034002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/08/2018

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 04/30/2022
• Device Catalogue Number: 32250320S
• Device Lot Number: K05B834
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2018
• Initial Date Received by Manufacturer: 05/21/2018
• Supplement Date Received by Manufacturer: 10/11/2018
• Initial Report FDA Received Date: 06/12/2018
• Supplement Report FDA Received Date: 11/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention