MAUDE Adverse Event Report: SMITH & NEPHEW, INC. FOOTPRINT ULTRA PK SUTURE ANCHOR 4.5; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Model Number 72202901

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 08/06/2020

Event Type  Injury  

Event Description

It was reported that during shoulder rotator cuff repair surgery, the footprint ultra anchor fractured (broke) when screwed-in.Device was retrieved from the patient.The procedure was completed without delay using a s+n backup device.No further complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

H10 h3, h6: one 72202901 footprint ultra pk suture anchor product used in treatment, was returned for evaluation.Threader with suture was returned.The anchor was returned separated from the inserter.There was no apparent damage to the inserter itself.Audible click upon rotation of the torque limiter was confirmed.The inner shaft advanced and retracted with rotations as expected.The anchor had barbs at the distal end missing.The inner anchor grub had been completely advanced through the outer anchor¿s distal tip.The distal fragment was not found.The condition is aligned with excess force and torque applied.This may be due to unexpected bone density or with an inadequate prep hole.Per instructions for use: it is the surgeon¿s responsibility to be familiar with the appropriate surgical techniques prior to use of this device.Prep instrument for normal bone conditions is a 3.8mm straight awl.Use the appropriate smith and nephew hole preparation device to prepare the insertion site.Smith and nephew disposable and reusable awls specific to the suture anchor are sold separately.Complaint history review indicated no similar allegations for the lot number reported.Batch review did not indicate a condition, product or procedure failure that supported the allegation.Instructions for use contains recommendations and precautionary statements for proper use of product.Risk management files contain the reported failure.Various quality checks are in place to ensure that the material of the device meets requirements defined and validated in the design process.No indications from the device show cause that the material was related to the reported failure.Product met specifications upon release to distribution.No root cause related to the manufacture of the device was confirmed.

Event Description

It was reported that during shoulder rotator cuff repair surgery, the footprint ultra anchor fractured (broke) when screwed-in.All pieces were retrieved from the patient using tweezers.The procedure was completed without delay using a s+n backup device in the original bone hole.No further complications were reported and the patient outcome is good.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

• Brand Name: FOOTPRINT ULTRA PK SUTURE ANCHOR 4.5
• Type of Device: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 10469990
• MDR Text Key: 204865963
• Report Number: 1219602-2020-01331
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 03596010650528
• UDI-Public: 03596010650528
• Combination Product (y/n): N
• PMA/PMN Number: K093897
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 09/29/2020

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 72202901
• Device Catalogue Number: 72202901
• Device Lot Number: 2049863
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2020
• Initial Date Manufacturer Received: 08/06/2020
• Initial Date FDA Received: 08/31/2020
• Supplement Dates Manufacturer Received: 08/26/2020; 09/28/2020
• Supplement Dates FDA Received: 09/09/2020; 09/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention