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

Model Number	72200636
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference: case-2021-00043558-1.
Event or Problem Description
It was reported that rail clamps box contained 2 pieces with different serial number, but the outer box only displayed 1 piece serial number.Additionally, the original label information was missing.No case reported; therefore, there was no patient involvement.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
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)
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• MDR Report Key: 11566538
• Report Number: 3003604053-2021-00117
• Device Sequence Number: 14332913
• Product Code: LXH
• UDI-Device Identifier: 00885554014518
• UDI-Public: 00885554014518
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/21/2021

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 Model Number: 72200636
• Device Catalogue Number: 72200636
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 03/01/2021
• Supplement Date Received by Manufacturer: 10/21/2021
• Initial Report FDA Received Date: 03/24/2021
• Supplement Report FDA Received Date: 10/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1