MAUDE Adverse Event Report: SMITH & NEPHEW, INC. INTUBATION DRAPER BAR; ACCESSORIES, OPERATING-ROOM, TABLE (KIT)

Model Number	7210563
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/16/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Event or Problem Description
It was reported that during arthroscopy procedure, outside the patient, the intubation draper bar could not be attached to a head rest, came off during the surgery.The procedure was completed with the same device to strengthen the fixation by surgical drape.No surgical delay.No patient injuries and complications were reported.
Additional Manufacturer Narrative
The device, used in treatment, was received for evaluation.There was a relationship found between the returned device and the reported incident.A visual inspection was performed.There were wear marks in the hexagonal opening.There appears to be damage on the outer lip of the hexagonal opening.A functional evaluation was conducted.The device could not be slid onto a test hexagonal bar.It could not be slid at all on the damaged lip side.If inserted the other direction it would slide the length of the hexagonal opening until it reached the damaged lip side of the opening and it would stop.An analysis of the customer provided images appears to show the intubation bar attached to a hex shaft.It appears that the intubation bar was not sliding onto the hex shaft beyond the very edge of the hex bar.The complaint was confirmed.Factors that could have contributed to the reported event include inadvertent impact inconsistent with intended use.A review of the device history record shows there are no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review concluded this was a repeat issue.No containment or corrective actions are recommended at this time.

• Brand Name: INTUBATION DRAPER BAR
• Common Device Name: ACCESSORIES, OPERATING-ROOM, TABLE (KIT)
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107
• MDR Report Key: 11798648
• Report Number: 1643264-2021-01763
• Device Sequence Number: 1020471
• Product Code: FWZ
• UDI-Device Identifier: 03596010513762
• UDI-Public: 03596010513762
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/09/2021

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 Model Number: 7210563
• Device Catalogue Number: 7210563
• Device Lot Number: 7560
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2021
• Initial Date Received by Manufacturer: 04/20/2021
• Supplement Date Received by Manufacturer: 06/08/2021
• Initial Report FDA Received Date: 05/10/2021
• Supplement Report FDA Received Date: 06/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1