MAUDE Adverse Event Report: STRYKER TRAUMA KIEL TIBIAL NAIL, STANDARD T2 TIBIA Ø11X330 MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number 1822-1133S

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Irritation (1941); Reaction (2414)

Event Date 12/04/2019

Event Type  Injury  

Manufacturer Narrative

Device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Device is not available for return, device is still implanted.

Event Description

It was reported, allergic reaction, skin redness 10 weeks post surgery.

Manufacturer Narrative

Received product data revealed the item was manufactured with titanium ti6al4v eli (astm f 136) which is intended for implantation.No indications of material, manufacturing or design related problems were found during the investigation.The reported issue is known within the product's risk management file.Based on the insufficient information provided, the root cause could not be determined.If any additional information is provided, the investigation will be reassessed.

Event Description

It was reported, allergic reaction, skin redness 10 weeks post surgery.

• Brand Name: TIBIAL NAIL, STANDARD T2 TIBIA Ø11X330 MM
• Type of Device: 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: 9522106
• MDR Text Key: 178642483
• Report Number: 0009610622-2019-00995
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 04546540198037
• UDI-Public: 04546540198037
• Combination Product (y/n): N
• PMA/PMN Number: K003018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 01/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/30/2021
• Device Model Number: 1822-1133S
• Device Catalogue Number: 18221133S
• Device Lot Number: K021CB7
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 34 YR