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

Catalog Number	30600095S
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Failure of Implant (1924)
Date of Event	06/19/2019
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
It was reported that the patient's left femur was revised due to femoral periprosthetic fracture, and breakage of the nail at the fracture site.Patient was revised to competitor devices.
Event or Problem Description
It was reported that the patient's left femur was revised due to femoral periprosthetic fracture, and breakage of the nail at the fracture site.Patient was revised to competitor devices.
Additional Manufacturer Narrative
This device is concomitant and did not contribute to the reported failure.Therefore, this complaint is closed without further investigation.As in the event description clearly mentioned that "it was reported that the patient's left femur was revised due to femoral periprosthetic fracture, and breakage of the nail at the fracture site.Possible cause or contributor to periprosthetic or device fracture was not reported to the rep.Patient was revised to competitor devices." if any additional information is provided indicating otherwise the record will be reopened and the investigation will be reworked.

• 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: 8784556
• Report Number: 0009610622-2019-00536
• Device Sequence Number: 1668088
• Product Code: HSB
• UDI-Device Identifier: 04546540374936
• UDI-Public: 04546540374936
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K032244
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/20/2019

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: 30600095S
• Device Lot Number: K0985B6
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/19/2019
• Supplement Date Received by Manufacturer: 08/22/2019
• Initial Report FDA Received Date: 07/12/2019
• Supplement Report FDA Received Date: 09/20/2019
• 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: 77 YR