MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LONG NAIL KIT R1.5, TI, LEFT GAMMA3® Ø11X300MM X 125°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	35251300S
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Information (3190)
Date of Event	08/08/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reported event could be confirmed, since the returned device was received broken.The device was implanted in (b)(6) 2018 and breakage was detected in (b)(6) 2019 when explantation took place, therefore the device was implanted for more than 6 months.The patient reported pain prior to explantation.Visual inspection of the device when returned revealed scuff marks on the inner linings of the lag screw hole consistent with drilling patterns.Closer inspection reveals distinct breakage patterns on either lateral side of the lag screw hole on the nail.The first pattern has characteristics consistent with gradual material fatigue while the second pattern has characteristics consistent with an instant fracture.The first pattern is within close proximity to the position where the drilling scuff marks on the inner linings of the lag screw hole are located.Scuff marks were also discovered on the nail at the tip of the entry point for the set-screw as well as on the set-screw thread in the nail.Severe abrasion was observed on the inner lining of one of the locking screw holes and can be matched with severe abrasions on one of the locking screws.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.Root cause is user related and attributed to a series of events starting from fatigue fracture at a lateral side of the lag screw hole in close proximity to the drilling scuff marks and ending with an instant fracture on the second lateral side of the lag screw hole after implantation duration of approx.9 months.If any further information is provided, the complaint report will be updated.
Event or Problem Description
As reported: "breakage of the gamma 3 nail.Nail has to be removed.Exact event date is unknown.Revision surgery on (b)(6) 2019.".

• Brand Name: LONG NAIL KIT R1.5, TI, LEFT GAMMA3® Ø11X300MM 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: 8974116
• Report Number: 0009610622-2019-00638
• Device Sequence Number: 11586858
• Product Code: HSB
• UDI-Device Identifier: 07613252274254
• UDI-Public: 07613252274254
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K034002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/09/2019

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 Catalogue Number: 35251300S
• Device Lot Number: K086D2C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/13/2019
• Initial Report FDA Received Date: 09/09/2019
• 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: 87 YR
• Patient Weight: 85