MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LAG SCREW, TI GAMMA3® Ø10.5X95MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	30600095S
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	Pain (1994)
Date of Event	06/04/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
Event or Problem Description
Gamma3 primary surgery was performed on (b)(6) 2014.This time cutout of the lag screw was found.It is unknown when the cutout was occurred.The patient has felt pain but is able to walk.Revision surgery to tha was performed on (b)(6) 2019.
Additional Manufacturer Narrative
The reported event could be confirmed, based on evaluation of x-rays and returned device.Visual inspection revealed that the received lag screw shows traces of use.Marks of bearing points were observed on lag screw surface.Locking screw thread were deformed near proximal end point due to repositioning of lag screw.Based on evaluation of the device and the provided medical data, the root cause was attributed to a patient related issue.The failure was mostly caused by the poor bone stock and the loads resulting from the obese patient.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 manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.The ifu states: ¿conditions attributable to non-union, osteoporosis, osteomalicia, diabetes, inhibited revascularization and poor bone formation can cause loosening, bending, cracking, fracture of the device or premature loss of rigid fixation with the bone.¿ if any further information is provided, the complaint report will be updated.
Event or Problem Description
Gamma3 primary surgery was performed on (b)(6) 2014.This time cutout of the lag screw was found.It is unknown when the cutout was occurred.The patient has felt pain but is able to walk.Revision surgery to tha was performed on (b)(6) 2019.

• Brand Name: LAG SCREW, TI GAMMA3® Ø10.5X95MM
• 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: 8732812
• Report Number: 0009610622-2019-00512
• Device Sequence Number: 2572190
• Product Code: HSB
• UDI-Device Identifier: 04546540374936
• UDI-Public: 04546540374936
• Combination Product (Y/N): N
• PMA/510(K) Number: K032244
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/30/2019

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: 01/31/2019
• Device Catalogue Number: 30600095S
• Device Lot Number: K0276B9
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2019
• Initial Date Received by Manufacturer: 06/04/2019
• Supplement Date Received by Manufacturer: 07/09/2019
• Initial Report FDA Received Date: 06/25/2019
• Supplement Report FDA Received Date: 07/30/2019
• 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: 80 YR
• Patient Weight: 75