MAUDE Adverse Event Report: SMITH & NEPHEW, INC. FEMORAL HEAD/NECK IMPACTOR; PRSTHEIS,HIP,SMICONSTRIND, UNCMNTD, METAL/POLYMR,NONPOROUS, CALICUMPHOSPHTE

Model Number 71360093

Device Problem Break (1069)

Patient Problem Injury (2348)

Event Date 08/04/2020

Event Type  malfunction  

Event Description

It was reported that during a hip revision procedure using the redapt stem kit, the surgeon was using the femoral head impactor to impact a ceramic femoral head onto the redapt stem.The surgeon only used one tap with a mallet on the impactor to seat the femoral head when a piece of the black plastic on the tip of the impactor broke off.This piece landed on the drape covering the patient and was immediately retrieved.No harm came to the patient and the procedure was completed as normal.There was no surgical delay.

Manufacturer Narrative

Results of investigation: the device, used in treatment, was returned for evaluation.A visual inspection confirms a piece of the black femoral head fractured off.The broken piece was not returned with the device.This device shows signs of significant wear/usage.This device was manufactured in 2016.A medical investigation was conducted and this case reports that an impactor broke upon impaction.Per email communication, the broken piece landed on the patient drape and was retrieved, and no harm or injury came to the patient.The procedure was completed as normal without a surgical delay.Since no harm is alleged, no further clinical assessment is warranted.A review of complaint history on the listed part revealed no prior complaint for the listed batch with the same failure mode.A review of the manufacturing records did not reveal any manufacturing or material abnormalities that could have caused or contributed to the reported incident.A review of risk management files found that the reported failure was documented appropriately.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.

Manufacturer Narrative

The device, used in treatment, was returned for evaluation.A visual inspection confirms a piece of the black femoral head fractured off.The broken piece was not returned with the device.This device shows signs of significant wear/usage.This device was manufactured in 2016.A medical investigation was conducted and this case reports that an impactor broke upon impaction.Per email communication, the broken piece landed on the patient drape and was retrieved, and no harm or injury came to the patient.The procedure was completed as normal without a surgical delay.Since no harm is alleged, no further clinical assessment is warranted.A review of complaint history on the listed part revealed no prior complaint for the listed batch with the same failure mode.A review of the manufacturing records did not reveal any manufacturing or material abnormalities that could have caused or contributed to the reported incident.A review of risk management files found that the reported failure was documented appropriately.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.

• Brand Name: FEMORAL HEAD/NECK IMPACTOR
• Type of Device: PRSTHEIS,HIP,SMICONSTRIND, UNCMNTD, METAL/POLYMR,NONPOROUS, CALICUMPHOSPHTE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10460244
• MDR Text Key: 204564088
• Report Number: 1020279-2020-04246
• Device Sequence Number: 1
• Product Code: MEH
• UDI-Device Identifier: 03596010619310
• UDI-Public: 03596010619310
• Combination Product (y/n): N
• PMA/PMN Number: K113789
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 02/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 71360093
• Device Catalogue Number: 71360093
• Device Lot Number: 1CM21854
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2020
• Date Manufacturer Received: 01/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 87 YR