MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LONG NAIL KIT R2.0, TI, LEFT GAMMA3® Ø11X380MM X 125°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	3325-0380S
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Injury (2348); Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	02/25/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Hospital retained device.
Event or Problem Description
It was reported that the patient's left femur was revised due to non-union and a broken gamma nail at the junction with the lag screw.Possible cause or contributor for implant breakage was not reported to the rep.Rep confirmed that no further information is available.
Event or Problem Description
It was reported that the patient's left femur was revised due to non-union and a broken gamma nail at the junction with the lag screw.Possible cause or contributor for implant breakage was not reported to the rep.Rep confirmed that no further information is available.
Additional Manufacturer Narrative
The reported event could not be confirmed, since the device was not returned for evaluation and no other evidence was provided.A device inspection was not possible since the affected device was not returned, and no other evidence was provided for investigation.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.More detailed information about the complaint event as well as the affected device, patient¿s medical records and x-rays must be available in order to determine the root cause of the complaint event.If the device is returned or if any additional information is provided, the investigation will be reassessed.

• 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; DE D-24232
• MDR Report Key: 9845303
• Report Number: 0009610622-2020-00112
• Device Sequence Number: 10947799
• Product Code: HSB
• UDI-Device Identifier: 07613153313533
• UDI-Public: 07613153313533
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K034002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/13/2020

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: 04/30/2022
• Device Model Number: 3325-0380S
• Device Catalogue Number: 33250380S
• Device Lot Number: K0649D1
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/25/2020
• Supplement Date Received by Manufacturer: 04/16/2020
• Initial Report FDA Received Date: 03/17/2020
• Supplement Report FDA Received Date: 05/13/2020
• 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: 87 YR
• Patient Weight: 56