MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SUTUREFIX ULTRA AHR XL, #2 UB BLUE/WH; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Model Number	72203842
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	03/02/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the suture fix xl anchor was placed in acetabular rim.Upon removal of implant inserter an x-ray was taken.The two prongs on the distal tip of the implant inserter broke off and were embedded in the patient¿s bone.Surgeon attempted to remove the broken piece but it was too far into bone so it was left.Unsure of how the inserter broke.Procedure was completed with a back-up device.No patient injury reported.
Additional Manufacturer Narrative
Definitive conclusions, accurate investigation and evaluation are not possible since product was not returned by customer for evaluation.No further actions pursued at this time.A manufacturing dhr review was performed by investigator revealed no other complaints or non-conformities for this production lot.

• Brand Name: SUTUREFIX ULTRA AHR XL, #2 UB BLUE/WH
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 7349017
• Report Number: 1219602-2018-00345
• Device Sequence Number: 13888364
• Product Code: MBI
• UDI-Device Identifier: 00885554031553
• UDI-Public: (01)00885554031553(17)220919(10)50686058
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K122059
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/10/2018

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 Expiration Date: 09/19/2022
• Device Model Number: 72203842
• Device Catalogue Number: 72203842
• Device Lot Number: 50686058
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/02/2018
• Supplement Date Received by Manufacturer: 03/02/2018
• Initial Report FDA Received Date: 03/19/2018
• Supplement Report FDA Received Date: 04/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1