MAUDE Adverse Event Report: SMITH & NEPHEW, INC. 10MM REAMER HEAD; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	E0016884-3
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/16/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during the procedure, the device was broke inside the patient.The procedure had a delay between 0-30 min.It is unknown how was the procedure finished.
Additional Manufacturer Narrative
Updated g3/g4: date received by manufacturer.
Additional Manufacturer Narrative
The associated device, used in treatment, was returned and evaluated.A visual inspection of the returned device did not confirmed the stated failure mode.A visual of the device did confirm the tip of the device is damaged, worn, and contains some burrs, rendering the device inoperative.The device shows signs of extensive use.The clinical/medical evaluation concluded that based on the information provided, the patient impact beyond the reported instrument breakage and possible retained foreign body of a non-implantable device could not be confirmed but based photos of the returned parts, if by chance there was a retained foreign body, then it would be small fragments.Corrosion/local irritation and possible migration of a potentially retained foreign body fragment(s) could not be ruled out for either event.No further medical assessment is warranted at this time.Should clinically relevant documentation/information become available, the clinical/medical task may be re-evaluated.A review of complaint history did not reveal additional complaints for the listed batch.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 do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the risk management file revealed this failure mode was previously identified.This device is a reusable instrument that can be exposed to numerous surgeries.Damage from prolonged use, misuse or rough handling are probable causes of the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.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 is warranted for this complaint; however, we will continue to monitor future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: 10MM REAMER HEAD
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10805125
• Report Number: 1020279-2020-06278
• Device Sequence Number: 14396118
• Product Code: LXH
• UDI-Device Identifier: 00885556777640
• UDI-Public: 885556777640
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/01/2021

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
• Operator of Device: Health Professional
• Device Catalogue Number: E0016884-3
• Device Lot Number: 102617
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2020
• Initial Date Received by Manufacturer: 10/19/2020
• Supplement Date Received by Manufacturer: 07/16/2020; 09/01/2021
• Initial Report FDA Received Date: 11/06/2020
• Supplement Report FDA Received Date: 12/03/2020; 09/01/2021
• 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