MAUDE Adverse Event Report: SMITH & NEPHEW, INC. OBTURATOR; INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Catalog Number	71674078
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/21/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgery, the black end of the obturator has sheared off.There was no delay and a backup device was available.Device broke while it was being used but no piece left inside reported.
Additional Manufacturer Narrative
The associated complaint device was returned and evaluated.A visual inspection of the obturator confirms the black knob broke off the device.All broken pieces were returned.The device shows significant signs of wear/usage.This device was manufactured in 1994.A complaint history and dhr review not performed for this event, as no manufacturing, packaging or labelling defects were associated with the reported failure.We recommend that all re-usable instruments be routinely inspected for wear/damage and replaced as necessary.Based on this investigation, the need for corrective action is not indicated.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.

• Brand Name: OBTURATOR
• Common Device Name: INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8735749
• Report Number: 1020279-2019-02454
• Device Sequence Number: 19476218
• Product Code: MDM
• UDI-Device Identifier: 03596010560742
• UDI-Public: 03596010560742
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 71674078
• Device Lot Number: 4500031704
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2019
• Initial Date Received by Manufacturer: 05/28/2019
• Supplement Date Received by Manufacturer: 05/28/2019
• Initial Report FDA Received Date: 06/26/2019
• Supplement Report FDA Received Date: 08/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1