MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LOCKING SCREW, FULLY THREADED T2 TIBIA 5X47,5 MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	1896-5047S
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Ambulation or Postural Difficulties (2544); Limb Fracture (4518); Implant Pain (4561)
Date of Event	08/06/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reported event could be confirmed, since the device was returned for evaluation and matches the alleged failure mode.Device inspection revealed the following: the received screw was found to be broken from the mid-shaft region.Although lines of rest are not remarkably visible, but they are present on the breakage surface very slightly.Along with that, the smooth topography indicates towards a fatigue fracture due to high cyclic loading.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.Based on the above investigation, it can be said that the root cause of the breakage is both user and patient related.The screw broke in a fatigue manner which is a sign of high cyclic loading.This loading can be a result of early nail breakage (as in this case) as well as due to high compressive loading (a likelihood of a non-union is also there), which is attributed to a patient related issue.But due to unavailability of critical patient¿s record at the time of evaluation and the fact that there was an intra-op damage of nail, the root cause is determined to be user related, predominantly.If any further information is provided, the complaint report will be updated.
Event or Problem Description
The customer reports the following: material breakage without external influence.The patient is announced to us by the (b)(6) with another periprosthetic femur fracture on the left side.The patient had fallen on the stairs while cleaning at home on (b)(6) 2020 and suffered a subtrochanteric femur fracture on the left side.She was treated as described above on (b)(6) 2020 at the (b)(6).The intra- and postoperative course was unremarkable.The patient underwent a rehabilitation measure, which also did not show any abnormalities.During the last weeks, increasing complaints on the left side with groin pain developed.For a few days now, the symptoms have been increasing significantly.The patient did not fall again.She has already had problems walking for several weeks, and stress-related pain.In further diagnostics, the peri-implant fracture with of the implanted gamma nail on the left side is shown and the patient is transferred to our clinic.Removal of material and reosteosynthesis using pfn 340/12 in domo.

• Brand Name: LOCKING SCREW, FULLY THREADED T2 TIBIA 5X47,5 MM
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• MDR Report Key: 10690772
• Report Number: 0009610622-2020-00566
• Device Sequence Number: 14269583
• Product Code: HSB
• UDI-Device Identifier: 04546540382351
• UDI-Public: 04546540382351
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K003018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/16/2020

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: 09/30/2020
• Device Model Number: 1896-5047S
• Device Catalogue Number: 18965047S
• Device Lot Number: K0D9934
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/08/2020
• Initial Report FDA Received Date: 10/16/2020
• 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: 76 YR