MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SWIVEL CLAMP; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY

Model Number	71934656
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/29/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a procedure the swivel clamp could not be fixed in the desired position.It is unknown if the patient suffer any surgical intervention due to this malfunction.No delay or the use a back up has been confirmed at this time.
Additional Manufacturer Narrative
Results of investigation: the device, used in treatment, was not returned for evaluation.Therefore, product analysis could not be performed at this time.So the reported event could not be confirmed.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.This device is a reusable instrument that can be exposed to numerous surgeries; damage from repeated use can occur.Damage from prolonged use, misuse or rough handling are likely probable causes of the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.We consider this investigation closed.
Additional Manufacturer Narrative
Additional information received identified that this event should be re-evaluated for mdr reporting.The reassessment determined that the issue does not meet the threshold for reporting and is a non-reportable event.This report was made based upon information which smith & nephew had not been able to investigate or verify prior to the required reporting date.The (b)(4) was found to be a duplicate of (b)(4) therefore the (b)(4) will be closed.The current investigation will be discarded.The correct investigation and findings will be performed under the (b)(4).
Additional Manufacturer Narrative
It has been confirmed that this event is a duplicate of (b)(4) reported under fda reference: 1020279-2021-00485.Therefore, this current event will be closed.

• Brand Name: SWIVEL CLAMP
• Common Device Name: PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11330953
• Report Number: 1020279-2021-01356
• Device Sequence Number: 2439932
• Product Code: JWH
• UDI-Device Identifier: 00885556235843
• UDI-Public: 00885556235843
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K951987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 71934656
• Device Catalogue Number: 71934656
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/25/2021
• Supplement Date Received by Manufacturer: 03/10/2021; 04/07/2021; 04/07/2021
• Initial Report FDA Received Date: 02/16/2021
• Supplement Report FDA Received Date: 04/06/2021; 04/07/2021; 04/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 46