MAUDE Adverse Event Report: STRYKER GMBH FEMORAL NAIL PF, LEFT T2 ALPHA FEMUR ANTEGRADE Ø11X360MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	2335-1136S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	04/18/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.Should additional information become available, it will be provided in a supplemental report.
Event or Problem Description
It was reported that the nail was removed due to a postoperative infection.
Additional Manufacturer Narrative
Please note the correction to d3.The reported event could not be confirmed, since the device was not returned and no additional information was available.A device inspection was not possible since the affected device was not returned and no other evidences were 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.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.More detailed information about the complaint event as well as the affected device 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.
Event or Problem Description
It was reported that the nail was removed due to a postoperative infection.

• Brand Name: FEMORAL NAIL PF, LEFT T2 ALPHA FEMUR ANTEGRADE Ø11X360MM
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 16945065
• Report Number: 0009610622-2023-00156
• Device Sequence Number: 17780800
• Product Code: HSB
• UDI-Device Identifier: 07613327285543
• UDI-Public: 07613327285543
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K191271
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/19/2023

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 Model Number: 2335-1136S
• Device Catalogue Number: 23351136S
• Device Lot Number: K04F378
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/20/2023
• Supplement Date Received by Manufacturer: 05/23/2023
• Initial Report FDA Received Date: 05/17/2023
• Supplement Report FDA Received Date: 06/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/07/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown