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

Catalog Number	33250380S
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Information (3190)
Date of Event	09/19/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available it will be provided on a supplemental report.
Event or Problem Description
It was reported that gamma nail broke after implantation.
Additional Manufacturer Narrative
The evaluation revealed the broken gamma3 long nail to be the primary product.No deviations were found during review of the manufacturing and inspection documents (dhr).The nail was documented as faultless prior to distribution.During investigation no material, design or manufacturing related issues were found.An inspection of the nail itself was not possible because the nail was not available.The provided x-rays confirmed the reported event: the nail was broken in its proximal nail hole.According to the provided surgery reports the nail broke after approx.7 months after implantation; it was further reported that the fracture was not healed (delayed healing).Also a multi fragment fracture was reported (most likely instable).According to stryker literature research a normal healing range of femur bones is <6 months (statement 040506rp2), therefore the not healed fracture was classified as non-union.Furthermore the patient¿s height and weight indicate most likely obesity.Additional details about the patient mobilization postoperatively were not reported.Non-unions, obesity and postoperatively loads in combination with an instable fracture are ifu and operative technique listed adverse effects that can lead to implant failures like reported in the actual case.Because no deviations were found during the dhr review a manufacturing related issue can be excluded.Most likely the nail broke in a fatigue fracture due to patient conditions.Review of complaint history, capa databases and risk analysis did not identify any discrepancies.There are no open actions in place related to the reported event for the subject product(s).No non-conformity was identified.
Event or Problem Description
It was reported that gamma nail broke after implantation.

• 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
• MDR Report Key: 6037881
• Report Number: 0009610622-2016-00472
• Device Sequence Number: 16413648
• Product Code: HSB
• UDI-Device Identifier: 07613153313533
• UDI-Public: 0107613153313533111508101720073110K0785FC
• 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: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/29/2016

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: 10/31/2020
• Device Catalogue Number: 33250380S
• Device Lot Number: K036884
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 09/19/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/18/2016
• Supplement Report FDA Received Date: 12/29/2016
• 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: 77 YR
• Patient Weight: 75