MAUDE Adverse Event Report: SMITH & NEPHEW, INC. HIP INSTRUMENT REPAIR; ARTHROPIERCE XL, STRAIGHT

Model Number 72202683

Device Problem Mechanics Altered (2984)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/01/2015

Event Type  malfunction  

Event Description

It was reported that the osteoraptor was implanted and then as sutures from anchor were passed through labrum they were cut by this (arthropierce xl straight) device.Surgeon used five anchors to repair and the first four were fine; it was the last one that cut two in a row.The procedure was a hip arthroscopy with labral repair.There was a two minute procedural delay.A backup device (different passer) was available.There were no reported patient injuries or complications.Adequate fixation was not achieved with the anchor's suture that the arthropierce cut.The cut suture was removed but the anchor was not.Another anchor was implanted and a different device was used to pass the suture achieving the fixation needed.

Manufacturer Narrative

Although anticipated, the device has not been received for analysis.(b)(4).

• Brand Name: HIP INSTRUMENT REPAIR
• Type of Device: ARTHROPIERCE XL, STRAIGHT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• Manufacturer Contact: meaghan atwell ; 150 minuteman road; andover, MA 01810 ; 9787491317
• MDR Report Key: 4805659
• MDR Text Key: 5928608
• Report Number: 1219602-2015-00118
• Device Sequence Number: 1
• Product Code: NBH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 05/01/2015

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 Model Number: 72202683
• Device Catalogue Number: 72202683
• Device Lot Number: 50397478
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/01/2015
• Initial Date FDA Received: 05/29/2015
• Date Device Manufactured: 11/19/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1