MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN OFFSET COUPLER TRIAL 4MM; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL

Model Number	71434302
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/07/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a revision surgery the lgn offset coupler trial 2mm broke.It is unknown if the revision was from s&n, if there was a delay or how the procedure was concluded.Patient injuries were not reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
Additional information received by the reporter has identified that this event should be re-evaluated for mdr reporting.The new information states that a serious injury- medical intervention has occurred since during procedure, the device broke inside the patient and pieces had to be removed from the medullary canal using general instruments, this event caused a delay of 90 minutes to the procedure.If further details are provided confirming the occurrence of a reportable event, our files will be updated accordingly and a further report submitted outlining both the event details and our investigations performed.
Event or Problem Description
It was reported that during a revision surgery of zimmer uni knee the lgn offset coupler trial 4mm broke while inside the patient, pieces were extracted from the medullary canal using general instruments.There was a delay of 90 mins.Other instrument in the set was used to complete the procedure.No other complications were reported at this time.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
The device, used in treatment was returned for evaluation.Visual inspection of the returned device confirms that the device is broken and has signs of wear and tear from use.The device was manufactured in 2013.A review of complaint history for the listed part revealed no prior complaints.A review of the manufacturing records did not reveal any manufacturing or material abnormalities that could have caused or contributed to the reported incident.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.The device is a reusable device that can be exposed to numerous surgeries and cleaning cycles.To avoid compromised performance or damage, it is recommended the device be inspected prior to and after each use and cleaning.We recommend that all re-usable instruments be routinely inspected for wear/damage and replaced as necessary.A review of risk management files and the instructions for use found that the reported failure was documented appropriately.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.No further actions are being taken at this time.
Additional Manufacturer Narrative
The device, used in treatment was returned for evaluation.Visual inspection of the returned device confirms that the device is broken and has signs of wear and tear from use.The device was manufactured in 2013.A review of complaint history for the listed part revealed no prior complaints.A review of the manufacturing records did not reveal any manufacturing or material abnormalities that could have caused or contributed to the reported incident.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.The device is a reusable device that can be exposed to numerous surgeries and cleaning cycles.Probable causes that could contribute to the reported event, as reusable instruments are susceptible to damage from prolonged use and through misuse or rough handling.To avoid compromised performance or damage, it is recommended the device be inspected prior to and after each use and cleaning.We recommend that all re-usable instruments be routinely inspected for wear/damage and replaced as necessary.A review of risk management files and the instructions for use found that the reported failure was documented appropriately.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.No further actions are being taken at this time.

• Brand Name: LGN OFFSET COUPLER TRIAL 4MM
• Common Device Name: PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10356935
• Report Number: 1020279-2020-03647
• Device Sequence Number: 2399280
• Product Code: HRY
• UDI-Device Identifier: 03596010547965
• UDI-Public: 03596010547965
• Combination Product (Y/N): N
• Initial Reporter Country: TC
• PMA/510(K) Number: K121393
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 12/01/2020

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 71434302
• Device Catalogue Number: 71434304
• Device Lot Number: 13JM02566
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2020
• Initial Date Received by Manufacturer: 07/08/2020
• Supplement Date Received by Manufacturer: 10/01/2020; 10/01/2020; 11/13/2020
• Initial Report FDA Received Date: 08/03/2020
• Supplement Report FDA Received Date: 10/01/2020; 10/27/2020; 12/01/2020
• 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