MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LONG NAIL KIT R1.5, TI, LEFT GAMMA3® Ø10X320MM X 125°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	3525-0320S
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/20/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
On (b)(6) 2016, long gamma nail was implanted as a treatment for trochanter fracture.Partial load was started 1 weeks later after surgery and total load started at 9 weeks.Felt something strange in (b)(6) 2018, visited the hospital on (b)(6) 2018.Fracture of the proximal part of the nail was discovered compared with radiographing.It was replaced on (b)(6) with a replacement of long gamma.
Additional Manufacturer Narrative
Correction to lot code.The reported event that long nail kit r1.5, ti, left gamma3® ø10x320mm x 125° was alleged of issue implant breakage - nail could not be confirmed, since the device was not returned for evaluation and no other evidences were 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.However, based on the complaint history and risk management file, some of the possible root causes can be: patient related like mechanical overstressing, traumatic overload, inadequate load or support, non-union and osteoporotic bone.Handling failure like implant was weakened / damaged when implanted; inadequate reposition, wrong nail geometry chosen, position of implant is incorrect, mislocking, misdrilling are less likely as failure happened after more than 2 years (else failure would have been sooner).Based on limited information and referring to that no deviation was found in the manufacturing documents a deficiency in the implant in question was not verified.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
On (b)(6) 2016, long gamma nail was implanted as a treatment for trochanter fracture.Partial load was started 1 weeks later after surgery and total load started at 9 weeks.Felt something strange in (b)(6) 2018, visited the hospital on (b)(6) 2018.Fracture of the proximal part of the nail was discovered compared with radiographing.It was replaced on (b)(6) with a replacement of long gamma.
Event or Problem Description
On 2016/12/16, long gamma nail was implanted as a treatment for trochanter fracture.Partial load was started 1 weeks later after surgery and total load started at 9 weeks.Felt something strange in march 2018, visited the hospital on april 10, 2018.Fracture of the proximal part of the nail was discovered compared with radiographing.It was replaced on april 20th with a replacement of long gamma.
Additional Manufacturer Narrative
The reported event that long nail kit r1.5, ti, left gamma3® ø10x320mm x 125° was alleged issue of implant breakage - nail could be confirmed, since the device was returned for evaluation and matched the alleged failure mode.The device inspection revealed the following: the nail was broken within its proximal hole for the lag screw.According to the damage and the evidences of the breakage surfaces, the nail broke in a fatigue fracture due to massive axial overload.Significant drill marks are found at the proximal hole for the lag screw; they progress through the entire bore.The drill marks were generated by a deviated lag screw step drill which most likely had created the starting point of the fracture by a notching effect.Drilling marks within the nail hole at the anterior bridge did most likely weakened the nail hole and favored the nail breakage.The customer reported that the nail was broken after approximately 2 years of implantation.According to an internal literature research the normal femur bone fracture consolidation is done after 8 to 24 weeks.A not healed bone after 6 months is classified as non-union, means the bone did not heal due to patient conditions.Based on the above observations the nail breakage is not linked to a deficiency of the device but is rather considered patient related (non-union/ delayed healing).The ifu addresses intra-operative implant damages and non-unions as warnings and adverse effects.If other listed adverse effects or contraindications (like instable fractures, obesity, high activity, osteoporosis, etc.) did contribute to the nail breakage could not be determined due to missing information.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 any further information is provided, the complaint report will be updated.No indications of material, manufacturing or design related problems were found during the investigation.

• Brand Name: LONG NAIL KIT R1.5, TI, LEFT GAMMA3® Ø10X320MM 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: 7507091
• Report Number: 0009610622-2018-00206
• Device Sequence Number: 18902957
• Product Code: HSB
• UDI-Device Identifier: 04546540375728
• UDI-Public: (01)04546540375728
• 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: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician Assistant
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/10/2018

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: 07/31/2021
• Device Model Number: 3525-0320S
• Device Catalogue Number: 35250320S
• Device Lot Number: K0B4454
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2018
• Initial Date Received by Manufacturer: 04/20/2018
• Supplement Date Received by Manufacturer: 07/19/2018; 09/20/2018
• Initial Report FDA Received Date: 05/11/2018
• Supplement Report FDA Received Date: 08/10/2018; 10/10/2018
• 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
• Patient Age: 70 YR