MAUDE Adverse Event Report: SMITH & NEPHEW, INC. US RAIL CLAMP (SUPINE DISTRACTOR SYS); ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number 72200636

Device Problem Device Markings/Labelling Problem (2911)

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

Event Date 12/29/2020

Event Type  malfunction  

Event Description

It was reported that the serial number of the english label on the outer box is inconsistent with the inner package.No case involved.Therefore, there was no patient involved.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).

Manufacturer Narrative

H10.During investigation, it was found that outer box was missing small label stickers that contain serial number information of both devices included in the box.As a result, these units received from supplier were not accepted at incoming inspection to add into inventory.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.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: US RAIL CLAMP (SUPINE DISTRACTOR SYS)
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• MDR Report Key: 11173969
• MDR Text Key: 241251506
• Report Number: 3003604053-2021-00011
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 00885554014518
• UDI-Public: 00885554014518
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 10/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 72200636
• Device Catalogue Number: 72200636
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1