MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG UNKN AARAU RECON KNEE INSTR; TEMPLATE

Catalog Number UNKN01400122

Device Problem Component Missing (2306)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/02/2021

Event Type  Injury  

Event Description

It was reported that, during a tka the rt plus modular loan instruments had a hole through the sterile wrap on one of those trays, ((b)(4)) instead it was used the rt plus monoblock loan instruments, however, the rt-plus sol drill w.Stop was missing from the kit ((b)(4)) therefore surgeon used a 3.2 pin drill to prepare the 6mm peg holes for the femoral cutting block.Also, surgeon could not assembles the tibial rt plus monoblock loan cutting jig in the reamer, ((b)(4)) instead had to use the gen ii tibial cutting jig.The procedure was completed with a delay less than or equal to 30min, using smith-nephew back-up devices.No patient injury or other complications were reported.

Manufacturer Narrative

It was reported that, during a total knee arthroplasty, using the rt plus monoblock loan instruments, the 6mm rt-plus drill with stop was missing from the kit and therefore, the surgeon used a 3.2 pin drill to prepare the 6mm peg holes for the femoral cutting block to insert into the femur.The procedure was completed with a delay less than 30min, using smith-nephew back-up devices.No patient injury or other complications were reported.The device, intended for use in treatment, was not returned for investigation.The production documentation and complaint history review could not be performed since the lot number was not provided.Based on performed medical investigation, smith+nephew is unable to rule out a procedural variance as a contributing factor to the reported event.According to the report, the surgeon was able to be complete the procedure with a delay less than 30min, using s+n compatible back-up devices.The reported the procedural modification did not result in patient injury, so no further medical assessment is warranted at this time.According to the document "processing, cleaning, disinfection and sterilization of instruments¿ from smith & nephew orthopaedics ag (lit.N°03389-en 1363 v3 11/19), all instruments must be inspected and controlled for proper functioning after cleaning/disinfection.Furthermore, instruments should only be used in their original condition (lit.No.Lit.No.12.24, ed.07/10).The failure mode and the severity of the reported issue are covered in the corresponding risk management file of s+n.However, it is unclear why the corresponding instrument was missing in the instrument set.Based on the conducted investigation, the root cause could not be determined conclusively and the need for corrective actions is not indicated.Should more information become available, the investigation will be reopened.No further actions are deemend necessary at the time.Smith+nephew will continue to monitor for similar issues.

• Brand Name: UNKN AARAU RECON KNEE INSTR
• Type of Device: TEMPLATE
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau CH-50 00; SZ CH-5000
• MDR Report Key: 11568235
• MDR Text Key: 242203812
• Report Number: 9613369-2021-00125
• Device Sequence Number: 1
• Product Code: HWT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKN01400122
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention