MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ACCORD TENSIONER; PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL

Catalog Number	71360020
Medical Device Problem Codes	Separation Failure (2547); Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/22/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during a revision internal fixation surgery, two (2) accord tensioner were used but then the locking handle became locked and not able to unlock.Multiple people tried of various size and build but no-one could unlock it.The surgery was completed, after a non-significant delay, changing the surgical technique.No injuries were reported.
Additional Manufacturer Narrative
Internal reference number: (b)(4).
Additional Manufacturer Narrative
H6 has been updated.
Additional Manufacturer Narrative
Additional information: d9 (received for analysis).Corrected data: b1 (product problem), h1 (removed serious injury), h6 (health effect - impact code).H11: this complaint has been reassessed based on the available information.It was determined that this event does not fulfill reporting requirements per 21cfr803.This event was inadvertently classified as a serious injury.The reported jamming experienced with the accord tensioner was not associated to a serious injury as previously indicated.In addition, there is no evidence suggesting that smith+nephew devices were involved with the revision performed on (b)(6) 2024.Investigative actions will be performed to determine the root cause of the reported issue.The applicable ifu recommends to inspect all reusable devices and replace any damaged units as necessary.This complaint will be monitored as per our standard post market surveillance plan.

• Brand Name: ACCORD TENSIONER
• Common Device Name: PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 19991310
• Report Number: 1020279-2024-01599
• Device Sequence Number: 12541547
• Product Code: JDG
• UDI-Device Identifier: 03596010485359
• UDI-Public: 3596010485359
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K123598
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/01/2024

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?: Yes
• Device Catalogue Number: 71360020
• Device Lot Number: 23KK00183
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/22/2024
• Supplement Date Received by Manufacturer: Not provided; 09/24/2024
• Initial Report FDA Received Date: 08/15/2024
• Supplement Report FDA Received Date: 09/03/2024; 10/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/26/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown