MAUDE Adverse Event Report: STRYKER GMBH TIBIAL NAIL T2 ALPHA? TIBIA Ø9X390MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	2341-0939S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	05/11/2021
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.A review of the device history is not possible because the lot number was not communicated.Should additional information become available, it will be provided on a supplemental report.H3 other text : device disposition is unknown.
Event or Problem Description
As reported: "a post-market clinical evaluation of the treatment of tibia fractures with the t2 alpha tibia nailing system: subject 01-008.Patient had pain over proximal and distal screws.Screws were removed on 14jul21, but not device.
Additional Manufacturer Narrative
Please note correction to (h6) health impact code.Following additional information received from the initial reporter, it was confirmed that the reported pain was resolved with the removal of the distal and proximal screws.This resolution took place on (b)(6) 2021.The tibia nail was left implanted without any complications; therefore, it was deemed a concomitant item.
Event or Problem Description
As reported: "a post-market clinical evaluation of the treatment of tibia fractures with the t2 alpha tibia nailing system: subject 01-008.Patient had pain over proximal and distal screws.Screws were removed on (b)(6) 2021, but not device.

• Brand Name: TIBIAL NAIL T2 ALPHA? TIBIA Ø9X390MM
• 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: 17295226
• Report Number: 0009610622-2023-00228
• Device Sequence Number: 7061693
• Product Code: HSB
• UDI-Device Identifier: 07613327290561
• UDI-Public: 07613327290561
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K191271
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/11/2023

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: 2341-0939S
• Device Catalogue Number: 23410939S
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/12/2023
• Supplement Date Received by Manufacturer: 08/09/2023
• Initial Report FDA Received Date: 07/10/2023
• Supplement Report FDA Received Date: 08/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 Age: 35 YR
• Patient Sex: Male
• Patient Weight: 75 KG