MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ANTHOLOGY INSERTER ANT SOFT; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Model Number 71365721

Device Problem Break (1069)

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

Event Date 12/07/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that during a thr procedure the tip of the anthology inserter ant soft broke off.This happened during use inside the patient.There was no delay.A s&n back up device was available to complete the procedure.No other complications were reported at this time.

Manufacturer Narrative

The device, used in treatment, was returned for evaluation.The clinical/medical team concluded, per complaint details, the device tip broke during a thr; however, the case was reportedly finished with a s+n backup device without reported patient harm or a surgical delay.No further complications were reported.Responses to medical documentation/information requests were not provided as of the time of this assessment.The clinical root cause could not be definitively concluded.The product evaluation will be performed and reported independent of the medical investigation.The patient impact beyond the reported use of a backup device to complete the procedure could not be determined as no injury or surgical delay/other complications were alleged.No further medical assessment is warranted at this time.A visual inspection confirmed the tip is broken off the anthology inserter ant soft and has not been returned.The device shows significant signs of wear/usage.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we have no reason to suspect that the products failed to meet any product specifications at the time of manufacture.A review of complaint history for the listed part revealed no prior complaints for the listed batch.A review of the risk management file revealed this failure mode was previously identified.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.This is a reusable instrument that can be exposed to numerous surgeries; damage from repeated use can occur.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.No further investigation warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: ANTHOLOGY INSERTER ANT SOFT
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11091116
• MDR Text Key: 224244043
• Report Number: 1020279-2020-07950
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 03596010553409
• UDI-Public: 03596010553409
• Combination Product (y/n): N
• PMA/PMN Number: K113789
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 02/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 71365721
• Device Catalogue Number: 71365721
• Device Lot Number: 16EM13553
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2020
• Date Manufacturer Received: 02/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1