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

Model Number	71631428
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/08/2020
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional 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
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10354131
• Report Number: 1020279-2020-03615
• Device Sequence Number: 2842449
• Product Code: HSB
• UDI-Device Identifier: 00885556158401
• UDI-Public: 00885556158401
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K122170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/26/2020

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 71631428
• Device Catalogue Number: 71631428
• Device Lot Number: 16ENG0140A
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/08/2020
• Supplement Date Received by Manufacturer: 11/18/2020
• Initial Report FDA Received Date: 08/01/2020
• Supplement Report FDA Received Date: 11/26/2020
• 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