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
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/10/2018
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
Gamma3 nail would be removed and replaced for a total hip prosthesis on (b)(6) 2018 by dr.(b)(6).Reason total hip prosthesis unknown.Gamma3 nail placed on (b)(6) 2013 by dr.(b)(6).Not known how that operation went.One distal screw is placed in the static hole.On x-ray photo it has been found that the distal screw is broken.Proximal part seems to be intact at that moment.The collum screw is removed and then the extractor is attached to the nail.Distal screw the lateral part is removed.When removing the gamma3 pen with extractor, the upper part breaks off.Remainder of the pen is removed with hook wire.The medial part of the distal screw remains in the patient and appears to cause damage to the cortex.It is decided to first make a ct and then decide which prosthesis can best be placed.New total hip surgery was postponed, patient still has a part of the distal screw in body.A ct scan has to be performed.
Event or Problem Description
Gamma3 nail would be removed and replaced for a total hip prosthesis on (b)(6) 2018 by dr.(b)(6).Reason total hip prosthesis unknown.Gamma3 nail placed on (b)(6) 2013 by dr.(b)(6).Not known how that operation went.1 distal screw is placed in the static hole.On x-ray photo it has been found that the distal screw is broken.Proximal part seems to be intact at that moment.The collum screw is removed and then the extractor is attached to the nail.Distal screw the lateral part is removed.When removing the gamma3 pen with extractor, the upper part breaks off.Remainder of the pen is removed with hook wire.The medial part of the distal screw remains in the patient and appears to cause damage to the cortex.It is decided to first make a ct and then decide which prosthesis can best be placed.New total hip surgery was postponed, patient still has a part of the distal screw in body.A ct scan has to be performed.
Additional Manufacturer Narrative
The reported event that long nail kit r2.0, ti, left gamma3® ø11x380mm x 125° was alleged of 'implant breakage - screw' could be confirmed.Based on investigation, the root cause was attributed to be user as well as user related.The failure was caused by the damage of the implant during the drilling by the user, which caused the weakening of the implant, as well as an axial overload on the implant, which caused the screw to break.The device inspection shows traces of drilling on one side of the lag hole of the nail.A closer inspection of that zone shows the presence of burrs also proving that a misdrilling occured.This most likely weakened the implant.The nail should have been discarded and replaced by a new one inter-operatively.An analysis of the broken screw, on the other hand, shows large and obvious deformation of the threads.This deformation occurs on the bearing part of the screw that is obviously located inside the nail.The screw broke on the bearing zone, most probably because of an axial overload.The breakage suface of the screw shows rest lines which are typical of a fatigue fracture.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 any further information is provided, the investigation report will be updated.

• 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: 7923899
• Report Number: 0009610622-2018-01340
• Device Sequence Number: 19231108
• Product Code: HSB
• UDI-Device Identifier: 07613153313533
• UDI-Public: 07613153313533
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K034002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/03/2019

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 12/31/2015
• Device Catalogue Number: 33250380S
• Device Lot Number: K266005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2018
• Initial Date Received by Manufacturer: 09/10/2018
• Supplement Date Received by Manufacturer: 12/06/2018
• Initial Report FDA Received Date: 10/01/2018
• Supplement Report FDA Received Date: 01/03/2019
• 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: 62 YR
• Patient Weight: 77