MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SUPINE TABLE ATTACHMENT (A2) W/PAD; APPARATUS, TRACTION, NON-POWERED

Catalog Number 72201725

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/23/2021

Event Type  malfunction  

Manufacturer Narrative

Internal complaint reference (b)(4).

Event Description

It was reported that during surgery, the "hip supine table attachment" broke.It is unknown how the surgery was completed or if there was any delay but they were able to get through the surgery.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

Internal complaint reference (b)(4).

Event Description

It was reported that during hip labral repair surgery, the "hip supine table attachment" broke.The procedure was completed with the same device and no significant delay or other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

Internal complaint reference (b)(4).H10: the information received by the manufacturer has been re-evaluated for mdr reporting and it was determined that this case does not meet the threshold for reporting and is a non-reportable event.Additional information received states that the initial malfunction reported did not cause any loss of traction and therefore there was no patient harm.If further details are provided confirming the occurrence of a reportable event, our files will be updated accordingly and a further report submitted outlining both the event details and our investigations performed.

• Brand Name: SUPINE TABLE ATTACHMENT (A2) W/PAD
• Type of Device: APPARATUS, TRACTION, NON-POWERED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• MDR Report Key: 11499362
• MDR Text Key: 244867759
• Report Number: 3003604053-2021-00093
• Device Sequence Number: 1
• Product Code: HST
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup,Followup
• Report Date: 04/06/2021

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
• Device Operator: Health Professional
• Device Catalogue Number: 72201725
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 02/24/2021
• Initial Date FDA Received: 03/16/2021
• Supplement Dates Manufacturer Received: 03/12/2021; 03/23/2021
• Supplement Dates FDA Received: 03/18/2021; 04/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1