MAUDE Adverse Event Report: SMITH & NEPHEW MAGNUM X WITH INDEPENDENT TENSIONING; FIXATION ANCHOR, LIGAMENT, NON-BIODE

Catalog Number OM-1503

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/13/2015

Event Type  malfunction  

Event Description

It was reported that during a shoulder procedure using a magnum x implant, the implant would not properly tighten.This deficiency resulted in an hour long surgical delay while the surgeon tried to get the implant to secure properly.There were no patient complications reported as a result of this event.

Manufacturer Narrative

The reported device was not returned for evaluation.Without the return of the reported device, an exact root cause cannot be determined with confidence.The evidence provided suggests that the most plausible root cause for the event was the user not adhering to the ifu.The reported procedure details provided by customer, indicate the device was implanted and suture tensioned prior to depressing the suture lock button, without performing the bone lock.Per ifu instructions, the suture is implanted, bone lock deployed, suture tensioned and then depress function switch.Without performing the bone lock, the device mechanism will not function as intended.

• Brand Name: MAGNUM X WITH INDEPENDENT TENSIONING
• Type of Device: FIXATION ANCHOR, LIGAMENT, NON-BIODE
• Manufacturer (Section D): SMITH & NEPHEW; austin TX
• Manufacturer Contact: wendy laird ; 7000 w william cannon dr; bldg 1; austin, TX 78735 ; 5123585933
• MDR Report Key: 4838083
• MDR Text Key: 5914797
• Report Number: 3006524618-2015-00088
• Device Sequence Number: 1
• Product Code: MBI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K081497
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/10/2015

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: OM-1503
• Device Lot Number: 1085164
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/13/2015
• Initial Date FDA Received: 06/09/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/10/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Weight: 105