MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LONG NAIL KIT R2.0, TI, LEFT GAMMA3® Ø11X380MM X 125°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	3325-0380S
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Injury (2348)
Date of Event	12/21/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is not available for return and is the subject of a legal matter.If additional information becomes available, it will be provided in a supplemental report.
Event or Problem Description
As reported by attorney: patient came in with pain.An x-ray of the hip and thigh on the left in two planes revealed the following findings: urgent suspicion of refracture of the previously described subtrochanteric femur fracture.The fracture gap is clearly visible.Buckling of the gamma nail at the level of the femoral neck screw as an indication of material breakage.Osteopenia.Revision on (b)(6) 2016.Gamma nail was removed and a new one was implanted.Stryker also became aware that patient has died on (b)(6) 2017.The cause of the death is unknown therefore the event will be reported separately.
Event or Problem Description
As reported by attorney: patient came in with pain.An x-ray of the hip and thigh on the left in two planes revealed the following findings: urgent suspicion of refracture of the previously described subtrochanteric femur fracture.The fracture gap is clearly visible.Buckling of the gamma nail at the level of the femoral neck screw as an indication of material breakage.Osteopenia.Revision on 21.12.2016.Gamma nail was removed and a new one was implanted.Stryker also became aware that patient has died on (b)(6) 2017.The cause of the death is unknown therefore the event will be reported separately.
Additional Manufacturer Narrative
The reported event could not be confirmed, since the device was not returned for evaluation and no other evidence was provided.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.Multiple attempts to retrieve this information has been made, but were unsuccessful.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.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Additional Manufacturer Narrative
The reported event could be confirmed, based only on the pictures of the broken gamma nail provided.The device was not returned but pictures were provided by the legal department.The visual inspection of the pictures could confirm that the reported nail was indeed broken at the level of the lag screw hole.No other statements could be extracted from the pictures, due to their very low resolution.An analysis of the lag screw or the breakage surface of the nail could not be made.Based on the documents received (surgery report and operative report, but no x-rays and no patient information such as weight, height, etc.), the expertise of a medical consultant was requested.His comments (excerpts): "the initial fracture was a pathological subtrochanteric fracture.These are very difficult to treat and the primary cause (of the fracture) needs to be treated as well, for example there might be a need for post-operative radiation therapy on the leg and other places were metastasis of the renal carcinoma appeared in the bones." however, the documents provided were not enough to assess the case, since the x-rays were not provided.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.No indications of material, manufacturing or design related problems were found during the investigation.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
As reported by attorney: patient came in with pain.An x-ray of the hip and thigh on the left in two planes revealed the following findings: urgent suspicion of refracture of the previously described subtrochanteric femur fracture.The fracture gap is clearly visible.Buckling of the gamma nail at the level of the femoral neck screw as an indication of material breakage.Osteopenia.Revision on (b)(6) 2016.Gamma nail was removed and a new one was implanted.Stryker also became aware that patient has died on (b)(6) 2017.The cause of the death is unknown therefore the event will be reported separately.

• Brand Name: LONG NAIL KIT R2.0, TI, LEFT GAMMA3® Ø11X380MM 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; DE D-24232
• MDR Report Key: 9555934
• Report Number: 0009610622-2020-00005
• Device Sequence Number: 14303639
• Product Code: HSB
• UDI-Device Identifier: 07613153313533
• UDI-Public: 07613153313533
• Combination Product (Y/N): N
• PMA/510(K) Number: K034002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/02/2020

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: 11/30/2020
• Device Model Number: 3325-0380S
• Device Catalogue Number: 33250380S
• Device Lot Number: K05B487
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/10/2019
• Supplement Date Received by Manufacturer: 03/04/2020; 05/06/2020
• Initial Report FDA Received Date: 01/06/2020
• Supplement Report FDA Received Date: 03/31/2020; 06/02/2020
• 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
• Patient Age: 72 YR