MAUDE Adverse Event Report: SMITH & NEPHEW, INC. 2.0 DRILL BIT {} QC 125/100; PLATE, FIXATION, BONE

Catalog Number 71176021

Device Problems Break (1069); Material Fragmentation (1261)

Patient Problem Death (1802)

Event Date 11/27/2018

Event Type  Death  

Event Description

It was reported that a surgery was performed on (b)(6) 2018 of a competitor device(depuy left total hip) and the x-ray showed what the surgeon believed to be a drill bit tip into the patient's hip/femur.Surgeon completed an incident report; however this was too late for the hospital to capture the other remaining piece of the drill as it was disposed of after surgery due to it being single use.From the report completed by the surgeon, the drill bit was unlikely to cause harm and unlikely to migrate, and he was happy to have periodic x-rays with the patient to ensure that the piece was not causing any harm.The patient died on the (b)(6) 2018 and the cause of death has not been given.The hospital has just reported the incident to us on 17/12/2018.The doctor does not feel that the retained fragment caused or contributed to this dead.Still awaiting for the coronial report to determinate if this was a device related issue.

Manufacturer Narrative

The associated reflection 3 hole shell was not returned for evaluation.Our investigation including a review of the manufacturing records for the listed part with the listed batch did not reveal any deviation from the standard manufacturing processes.A review of complaint history for the listed part revealed no prior complaints for the listed failure mode with the same batch number.Our clinical evaluation noted that the x-ray provided confirms the screw through the shell but details on placement or details of the screw were not included.Without additional information we can¿t comment on the stability of the cup or the placement of the screw through the cup as it does have 2 others.In addition, ¿the implantation of the screw under power¿, as a likely contributing factor cannot be ruled out.Since a revision has not been planned, the future impact to the patient beyond the possibility of screw migration cannot be determined.Should additionally clinical information be provided this complaint will be re-assessed.Without the return of the actual product involved, our investigation of this report is inconclusive.No further investigation warranted for this complaint; however smith and nephew will continue to monitor for future complaints and investigate as necessary.Should the device or additional information be received, the complaint will be reopened.We consider this investigation closed.

Manufacturer Narrative

The associated 2.0 drill bit was not returned for evaluation.Therefore a product analysis could not be performed.Our investigation including a review of the manufacturing records for the listed part with the listed batch did not reveal any deviation from the standard manufacturing processes.A review of complaint history for the listed part revealed no prior complaints for the listed failure mode with the same batch number.Our clinical evaluation noted that the alloy is not bio-inert nor approved for implantation and it remains unknown if corrosion, micro-motion and/or migration of the retained fragments were likely.Without the relevant clinical documents, i.E., the coroner report labs, surgical reports, the root cause of the broken drill bit a year prior to the reported death cannot be determined.It was reported that the surgeon, ¿did not feel that the retained fragment caused or contributed to this death".A relationship, if any, between the device and the adverse event could not be corroborated.Without the return of the actual product involved and no patient medical records available, our investigation of this report is inconclusive.No further investigation warranted for this complaint; however smith and nephew will continue to monitor for future complaints and investigate as necessary.Should the device or additional information be received, the complaint will be reopened.

• Brand Name: 2.0 DRILL BIT {} QC 125/100
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8244636
• MDR Text Key: 132951842
• Report Number: 1020279-2019-00152
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 03596010302748
• UDI-Public: 03596010302748
• Combination Product (y/n): N
• PMA/PMN Number: K123055
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup,Followup
• Report Date: 12/04/2019

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
• Device Operator: Health Professional
• Device Catalogue Number: 71176021
• Device Lot Number: 17LTMH050
• Initial Date Manufacturer Received: 12/17/2018
• Initial Date FDA Received: 01/14/2019
• Supplement Dates Manufacturer Received: 12/17/2018; 12/17/2018
• Supplement Dates FDA Received: 04/22/2019; 12/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death