MAUDE Adverse Event Report: STRYKER TRAUMA KIEL RECONSTRUCTION NAIL R2.0, TI, LEFT T2 RECON 11X340 MM X 125; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	1846-1134S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bacterial Infection (1735)
Date of Event	08/10/2020
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.
Event or Problem Description
"a ct scan of the pelvis subsequently revealed an intra-articular coxo-femoral screw on the right leg.Lag screw was revised the (b)(6) 2020." clarification received: "installed on (b)(6) 2020 : t2 femur clou recon 11x320mm gh reference : 1846-1134s lot : k037023.Following an infection of the osteosynthesis material left leg nail with staphylococcus epidermitis and acinetobacter baumannii, change of the material.Installed on 20/08/2020 : t2 femur clou recon 11x320mm gh reference : 1846-1132s lot : k880065ra (currently implanted)".
Additional Manufacturer Narrative
The reported event could not be confirmed, since no other evidence like medical reports were provided.A device inspection was not possible since the affected device was not returned and no other evidence was 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.No indications of manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.More detailed information about the complaint event, patient record and medical reports 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
"a ct scan of the pelvis subsequently revealed an intra-articular coxo-femoral screw on the right leg.Lag screw was revised the (b)(6) 2020." clarification received: "installed on 19/07/2020 : t2 femur clou recon 11x320mm gh reference : 1846-1134s lot : k037023.Following an infection of the osteosynthesis material left leg nail with staphylococcus epidermitis and acinetobacter baumannii, change of the material.Installed on (b)(6) 2020 : t2 femur clou recon 11x320mm gh reference : (b)(4) lot : k880065ra (currently implanted)".

• Brand Name: RECONSTRUCTION NAIL R2.0, TI, LEFT T2 RECON 11X340 MM X 125
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• MDR Report Key: 10583570
• Report Number: 0009610622-2020-00544
• Device Sequence Number: 16934475
• Product Code: HSB
• UDI-Device Identifier: 07613153316619
• UDI-Public: 07613153316619
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K032898
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 11/23/2020

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: 05/31/2023
• Device Model Number: 1846-1134S
• Device Catalogue Number: 18461134S
• Device Lot Number: K037023
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/31/2020
• Supplement Date Received by Manufacturer: 10/29/2020
• Initial Report FDA Received Date: 09/24/2020
• Supplement Report FDA Received Date: 11/24/2020
• 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: Required Intervention
• Patient Age: 28 YR