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

Model Number	3225-0380S
Health Effect - Clinical Codes	Fall (1848); Pain (1994); No Code Available (3191)
Date of Event	03/25/2017
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
It was reported that patient fall on ice and fracture subtroch.On (b)(6) 2016, gamma nail was implanted on (b)(6) 2016, no trauma, increasing pain during garden work, material removal and implantation of a long gamma nail (b)(6) 2016, increasing pain for 2 weeks, nail breakage, revision with a friedel nail on (b)(6) 2017.
Additional Manufacturer Narrative
The evaluation revealed the broken 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.No deficiency found during dimensional inspection of the returned product.The evaluation revealed that the nail broke in a fatigue fracture after a period of more than 8 months of implantation.According to found damages the fatigue fracture had its origination in the posterior web at lateral.In this area significant material damage had weakened the web caused by misaligned drilling with the step drill; which presents an unintentional use error.Significant material deformation (bearing points) of the medial edge of the proximal drill hole ¿ including additional material crack ¿ was most likely caused by increased axial loading during the implantation period; which is considered as patient behavior related.One requirement for successful nail treatment is a timely bone healing in order to relieve the nail over the progressing time of implantation.Potential adverse effects, e.G.Overweight, increased loading or material damage are clearly pointed out in the labeling.Based on the above the nail breakage was not linked to a deficiency of the device, but was mainly patient related (repeatedly impaired bone healing) combined with high loading (secondary crack) most likely contributed by an unintentional use error.Review of complaint history, capa databases and risk analysis did not identify any conspicuity.The review of the risk assessment for the failure mode indicated the issue was addressed adequately.There were no actions in place related to the reported event for the subject product.
Event or Problem Description
It was reported that patient fall on ice and fracture subtroch.On (b)(6) 2016, gamma nail was implanted on (b)(6) 2016, no trauma, increasing pain during garden work, material removal and implantation of a long gamma nail (b)(6) 2016, increasing pain for 2 weeks, nail breakage, revision with a friedel nail on (b)(6) 2017.

• Brand Name: LONG NAIL KIT R2.0, TI, RIGHT 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: 6513409
• Report Number: 0009610622-2017-00118
• Device Sequence Number: 1149293
• Product Code: HSB
• UDI-Device Identifier: 07613153312796
• UDI-Public: (01)07613153312796(11)160424(17)210331()10K02B03F
• 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: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/22/2017

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: 03/31/2021
• Device Model Number: 3225-0380S
• Device Catalogue Number: 32250380S
• Device Lot Number: K02B03F
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2017
• Initial Date Received by Manufacturer: 03/27/2017
• Supplement Date Received by Manufacturer: 08/29/2017
• Initial Report FDA Received Date: 04/21/2017
• Supplement Report FDA Received Date: 09/22/2017
• 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: 69 YR
• Patient Weight: 87