MAUDE Adverse Event Report: STRYKER GMBH TIBIAL NAIL T2 ALPHA? TIBIA Ø10X330MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	2341-1033S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Discomfort (2330); Skin Inflammation/ Irritation (4545); Implant Pain (4561)
Date of Event	09/14/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
A post-market clinical evaluation of the treatment of tibia fractures with the t2 alpha tibia nailing system subject 01-024.Subject has pain and discomfort with the interlocking screws.They cause redness over the subject's knees and the subject would like them removed.Removal of hardware procedure of screws was completed on (b)(6) 2021.
Additional Manufacturer Narrative
The reported event that the patient required revision surgery due to pain and discomfort could not be confirmed, since the device(s) were not returned for evaluation and no other additional information was received from the clinical site.More detailed information about the patient's medical history, the event details and the involved device(s) must be available to determine the root cause.   if any additional information becomes available, the investigation will be reopened and re-evaluated accordingly.H3 other text : device disposition unknown.
Event or Problem Description
A post-market clinical evaluation of the treatment of tibia fractures with the t2 alpha tibia nailing system.Subject (b)(6).Subject has pain and discomfort with the interlocking screws.They cause redness over the subject's knees and the subject would like them removed.Removal of hardware procedure of screws was completed on (b)(6) 2021.
Additional Manufacturer Narrative
Please note correction to h6 (health impact code).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 was not possible because the lot number was not communicated.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.Indications of material, manufacturing, or design related problems were unable to be identified as the lot number was not communicated.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.

• Brand Name: TIBIAL NAIL T2 ALPHA? TIBIA Ø10X330MM
• 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: 17309289
• Report Number: 0009610622-2023-00241
• Device Sequence Number: 7214027
• Product Code: HSB
• UDI-Device Identifier: 07613327291032
• UDI-Public: 07613327291032
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K191271
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Study
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/16/2023

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: 2341-1033S
• Device Catalogue Number: 23411033S
• Device Lot Number: UNKNOWN
• 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: 06/15/2023
• Supplement Date Received by Manufacturer: 07/20/2023
• Initial Report FDA Received Date: 07/12/2023
• Supplement Report FDA Received Date: 08/16/2023
• 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: 83 YR
• Patient Sex: Female
• Patient Weight: 81 KG