MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SUTUREFIX UL ANR XL W/1 #2 ULTRABRIAD BL; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Model Number	72203841
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/24/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that after completion of a labral repair with a suturefix ulta anchors.It was noted on the x-ray image a foreign body.It was a part of the anchor deployment device.The object was retrieved from the patient.Five anchors where used and it is unsure which device malfunctioned.
Additional Manufacturer Narrative
Due to no product return the complaint could not be ultimately confirmed.Definitive conclusions, accurate investigation and evaluation are not possible without product to evaluate.If objective evidence, relevant information or product becomes available to assist with evaluation, the complaint will certainly be revisited.
Additional Manufacturer Narrative
Four 72203841 suturefix ultra anchor xl devices returned.Complaint correspondence and attachments indicate that the following complaints were all related: c-(b)(4), c-(b)(4), c-(b)(4), c-(b)(4), and c-(b)(4) (c-(b)(4) closed as duplicate of c-(b)(4)).The complaint stated: "it was reported that after completion of a labral repair with a suturefix ultra anchors.It was noted on the x-ray image a foreign body.It was a part of the anchor deployment device.The object was retrieved from the patient.Five anchors where used and it is unsure which device malfunctioned.Retrieval of this foreign body took approx.2 hours with prolonged anesthesia time and traction on patient's lower leg." all five complaints were opened for the same failure.The container held four used devices.It was labeled as c-(b)(4).That complaint was routed to evaluation in (b)(4) and closed.These four are therefore the related remaining four devices.Because the devices are not labeled individually, they were evaluated together.The devices were all returned without suture or anchor.The devices were previously deployed.The outer insertion shafts are straight and undamaged.None of the nose tubes dented or bent.The inner shaft fork tines are intact on each insertion device.There is no obvious failure accounted for on any device.They are simply tainted and missing their suture/anchors.No root cause associated with the manufacture of this device was confirmed.

• Brand Name: SUTUREFIX UL ANR XL W/1 #2 ULTRABRIAD BL
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 7608477
• Report Number: 1219602-2018-00755
• Device Sequence Number: 1424415
• Product Code: MBI
• UDI-Device Identifier: 00885554030051
• UDI-Public: (01)00885554030051(17)220414(10)50658875
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K122059
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/25/2018

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 Expiration Date: 04/14/2022
• Device Model Number: 72203841
• Device Catalogue Number: 72203841
• Device Lot Number: 50658875
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2018
• Initial Date Received by Manufacturer: 06/01/2018
• Supplement Date Received by Manufacturer: 07/23/2018; 10/23/2018
• Initial Report FDA Received Date: 06/17/2018
• Supplement Report FDA Received Date: 07/24/2018; 10/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other