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

Model Number	1822-1133S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Irritation (1941); Reaction (2414)
Date of Event	12/04/2019
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
It was reported, allergic reaction, skin redness 10 weeks post surgery.
Additional 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 or Problem Description
It was reported, allergic reaction, skin redness 10 weeks post surgery.

• Brand Name: TIBIAL NAIL, STANDARD T2 TIBIA Ø11X330 MM
• Common Device Name: 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
• Report Number: 0009610622-2019-00995
• Device Sequence Number: 3012558
• Product Code: HSB
• UDI-Device Identifier: 04546540198037
• UDI-Public: 04546540198037
• Combination Product (Y/N): N
• PMA/510(K) Number: K003018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/29/2020

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: 09/30/2021
• Device Model Number: 1822-1133S
• Device Catalogue Number: 18221133S
• Device Lot Number: K021CB7
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/04/2019
• Supplement Date Received by Manufacturer: 01/03/2020
• Initial Report FDA Received Date: 12/26/2019
• Supplement Report FDA Received Date: 01/29/2020
• 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: Other
• Patient Age: 34 YR