MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ANTHOLOGY INSERTER POST SOFT; PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL

Model Number	71365706
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/21/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that during a thr, the tip of a anthology inserter post soft snapped off inside the patient.There was no significant delay and the procedure was finished using a smith & nephew back up.Patient was not harmed.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.¿.
Additional Manufacturer Narrative
H3, h6: the device, used in treatment, was returned for evaluation.A visual inspection was conducted and confirms during this inspection, that the anthology inserter fractured at the tip, most likely from impact.An impact fracture can occur if the mechanical loads applied to the instrument exceed the strength of the material.A fracture can also be the result of multiple impacts.This fracture caused the instrument to become inoperable.The device show signs of significant use/wear.The clinical/medical evaluation concluded that per email correspondence, there was no patient injury as a result of this device related incident, and the surgeon was able to retrieve the piece from the stem.The procedure was completed using a backup device, without significant delay.Therefore, no further medical assessment is warranted based on the information provided.A review of complaint history for the listed part revealed no prior complaints for the listed failure mode.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of the risk management file revealed this failure mode was previously identified.This device is a reusable instrument that can be exposed to numerous surgeries; damage from repeated use can occur.Expected wear/tear is likely the probable cause 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.Should additional information be received, the complaints will be reopened.No further investigation is warranted for these complaints; however we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: ANTHOLOGY INSERTER POST SOFT
• Common Device Name: PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11812540
• Report Number: 1020279-2021-04093
• Device Sequence Number: 19810928
• Product Code: JDG
• UDI-Device Identifier: 03596010555670
• UDI-Public: 03596010555670
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K123598
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2021

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: Health Professional
• Device Model Number: 71365706
• Device Catalogue Number: 71365706
• Device Lot Number: 18GM09806
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2021
• Initial Date Received by Manufacturer: 04/21/2021
• Supplement Date Received by Manufacturer: 07/20/2021
• Initial Report FDA Received Date: 05/12/2021
• Supplement Report FDA Received Date: 07/22/2021
• 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