MAUDE Adverse Event Report: SMITH & NEPHEW, INC. EUR/UK RAIL CLAMP (SUPINE DSTRCTR SYS); ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	72200670
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/15/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that during a hip ask the device's jaw broke causing a loss of traction.No instruments were inside the patient when the event occurred.The procedure was successfully completed with the same device.No significant delay or patient injury was reported.
Additional Manufacturer Narrative
Additional information was received that identified that this event should be re-evaluated for mdr reporting.The additional information received states that this device did not malfunction, the device that did fail is reported in mdr: 3003604053-2019-00110.The reassessment determined that the issue does not meet the threshold for reporting and is a non-reportable event.This report was made based upon information which smith & nephew had not been able to investigate or verify prior to the required reporting date.
Additional Manufacturer Narrative
Visual inspection and functional testing could not be performed because the device in question has not been returned for evaluation.A photo of the damage was provided however a root cause could not be determined with confidence.It is difficult to perform an accurate evaluation of a failure without having the failed product to look at.As such the complaint is being closed without conclusion.However, if the product is returned in the future the complaint can be reopened and evaluated.
Additional Manufacturer Narrative
H10: d4: additional information.

• Brand Name: EUR/UK RAIL CLAMP (SUPINE DSTRCTR SYS)
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• MDR Report Key: 8954002
• Report Number: 3003604053-2019-00111
• Device Sequence Number: 14053357
• Product Code: LXH
• UDI-Device Identifier: 03596010578112
• UDI-Public: 03596010578112
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/18/2019

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: 72200670
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/08/2019
• Supplement Date Received by Manufacturer: 08/08/2019; 10/01/2019; 10/10/2019
• Initial Report FDA Received Date: 09/02/2019
• Supplement Report FDA Received Date: 09/05/2019; 10/02/2019; 10/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1