MAUDE Adverse Event Report: SMITH & NEPHEW, INC. META-TAN COMP SCREW DRILL; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number 71631428

Device Problem Break (1069)

Patient Problems Foreign Body In Patient (2687); No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/08/2020

Event Type  Injury  

Event Description

It was reported that during the metatan procedure, the entry of the reamer was broke, inside the patient.The procedure had a delay between 0-30 min.There was a change in the surgical technique because the comp main reamer did not functional until the lag reamer was used.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

The device, intended for use 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.As per clinical/medical investigation, the product evaluation confirmed the reamer breakage and wear.However, the root cause of the reamer breakage could not be determined.The patient impact beyond the reported instrument breakage and possible retained foreign body of a non-implantable device could not be determined, although, corrosion/local irritation and possible migration of possible retained foreign body could not be ruled out.Per communications, the procedure completed with a change in the surgical technique because the comp main reamer was not functional until the lag reamer was used.Although there was a reported delay between 0-30 minutes in the procedure, there was no reported harm to the patient.Therefore, no further clinical/medical assessment is warranted at this time.The device was manufactured in 2016.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: META-TAN COMP SCREW DRILL
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10354131
• MDR Text Key: 201341757
• Report Number: 1020279-2020-03615
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 00885556158401
• UDI-Public: 00885556158401
• Combination Product (y/n): N
• PMA/PMN Number: K122170
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 11/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 71631428
• Device Catalogue Number: 71631428
• Device Lot Number: 16ENG0140A
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention