MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X37,5 MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	18965037S
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
This device is concomitant and did not contribute to the reported failure.Based on the investigation, the root cause was attributed to a patient-related issue.The failure was caused due to poor bone stock (osteoporotic bone) and the loads on the implant resulting from the obese patient.The event happened because of lag screw cut out.Due to this, the fixation became unstable and the whole load came up on the nail and locking screw.As a result of this, the locking screw got deformed.If any additional information is provided indicating otherwise the record will be reopened and the investigation will be reworked.
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: LOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X37,5 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
• MDR Report Key: 8732823
• Report Number: 0009610622-2019-00510
• Device Sequence Number: 2666475
• Product Code: HSB
• UDI-Device Identifier: 04546540382337
• UDI-Public: 04546540382337
• Combination Product (Y/N): N
• PMA/510(K) Number: K003018
• 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): 08/01/2019

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 Catalogue Number: 18965037S
• Device Lot Number: K05BF39
• 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: 08/01/2019
• 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