MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKN NON-ABSORBABLE SUTURE AND TAPE; SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE

Model Number	7210914
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Post Operative Wound Infection (2446)
Date of Event	04/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference (b)(4).Article cite: sahin, k., sentürk, f., ersin, m., arzu, u., chodza, m., & ersen, a.(2021).Repair integrity and functional outcomes between knot-tying and knotless suture-bridge arthroscopic rotator cuff repair: a prospective randomized clinical trial.Orthopaedic journal of sports medicine, 9(4), 23259671211002482.Https://doi.Org/10.1177/23259671211002482.
Event or Problem Description
It was reported that on literature review "repair integrity and functional outcomes between knot-tying and knotless suture-bridge arthroscopic rotator cuff repair: a prospective randomized clinical trial", one patient had a post-operative superficial active infection after a knot-tying rotator cuff repair procedure using an ultrabraid suture.This event was treated by administration of oral antibiotics.The patient was full recovered.No further information is available.
Additional Manufacturer Narrative
H3, h6: the reported device was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.There was no way to determine if the device contributed to the reported event.The complaint was not confirmed.Factors that could have contributed to the reported event include a failure of a concomitant device.Insufficient product identification information was provided, and thus, a manufacturing record review could not be conducted.A complaint history review concluded this was a repeat issue.The instructions for use was reviewed and found to include conditions of off label use and technique specifics, as well as precautions and warnings related to the use of the device.A review of risk management files found that there was insufficient information to tie the reported complaint to specific line items within the risk file.Our clinical investigation concluded: without clinically relevant patient-specific supporting documentation, a thorough medical investigation could not be performed.According to the article, this adverse event was treated by administration of oral antibiotics and the patient has fully recovered.Therefore, no further clinical/medical assessment is warranted at this time.Should any additional relevant medical information be provided, this complaint would be re-assessed.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.No containment or corrective actions are recommended at this time.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.

• Brand Name: UNKN NON-ABSORBABLE SUTURE AND TAPE
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 12896266
• Report Number: 1643264-2021-02444
• Device Sequence Number: 20062981
• Product Code: GAT
• UDI-Device Identifier: 03596010511942
• UDI-Public: 03596010511942
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• PMA/510(K) Number: K041216
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Study,Literature,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/11/2022

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 Model Number: 7210914
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/09/2021
• Supplement Date Received by Manufacturer: 02/24/2022
• Initial Report FDA Received Date: 11/30/2021
• Supplement Report FDA Received Date: 03/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown