MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LONG NAIL KIT R2.0, TI, LEFT GAMMA3 11X380MM X 125; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	3325-0380S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Limb Fracture (4518)
Date of Event	10/05/2020
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
The surgeon reported that the patient who had been implanted with a gamma long nail needs revision surgery.Additionally reported: patient presented in a&e on (b)(6) 2020.Patient tripped and fell, fresh fracture to the femur was noted, nail intact.Patient has fibrous dysplasia.
Additional Manufacturer Narrative
The reported event could be confirmed, through the additional patient documents and since the device was returned for evaluation.A device inspection revealed the following: the returned nail was observed to be intact without any significant damage except for a heavy bearing mark inside the distal oblong hole cause by the locking screw.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.Since there was no device malfunction/failure and device related harm to the patient, the root cause of the failure is attributed to a patient related factor.The patient underwent a revision surgery following a fall with a nail already inside, leading to a fresh fracture as confirmed through additional documents provided.If any further information is provided, the complaint report will be updated.
Event or Problem Description
The surgeon reported that the patient who had been implanted with a gamma long nail needs revision surgery.Additionally reported: patient presented in a&e on (b)(6) 2020.Patient tripped and fell, fresh fracture to the femur was noted, nail intact.Patient has fibrous dysplasia.

• Brand Name: LONG NAIL KIT R2.0, TI, LEFT GAMMA3 11X380MM 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; GM D-24232
• MDR Report Key: 10757461
• Report Number: 0009610622-2020-00618
• Device Sequence Number: 3334017
• Product Code: HSB
• UDI-Device Identifier: 07613153313533
• UDI-Public: 07613153313533
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K034002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/23/2020

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 07/31/2020
• Device Model Number: 3325-0380S
• Device Catalogue Number: 33250380S
• Device Lot Number: K09A571
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2020
• Initial Date Received by Manufacturer: 10/05/2020
• Supplement Date Received by Manufacturer: 11/27/2020
• Initial Report FDA Received Date: 10/29/2020
• Supplement Report FDA Received Date: 12/23/2020
• 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: 41 YR