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	Subluxation (4525)
Date of Event	05/01/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, on literature review "arthroscopic treatment of first-time shoulder dislocations in younger athletes", one patient had a subluxation after a arthroscopic procedure using an ultrabraid suture.No further action due to this event and the patient outcomes is unknown.No further information is available.
Additional Manufacturer Narrative
Internal complaint reference case-(b)(4).Article cite: terra, b.B., ejnisman, b., belangero, p.S., figueiredo, e., de nadai, a., ton, a., & cohen, m.(2019).Arthroscopic treatment of first-time shoulder dislocations in younger athletes.Orthopaedic journal of sports medicine, 7(5), 2325967119844352.Https://doi.Org/10.1177/2325967119844352.
Additional Manufacturer Narrative
H10, 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.Insufficient product identification information was provided and thus a manufacturing record review could not be conducted.Based on the information available, there were no indications to suggest that the product did not meet manufacturing specifications upon release for distribution.Insufficient product identification information was provided and thus a complaint history review could not be conducted.Insufficient product identification information was provided, and thus, an instruction for use review could not be conducted.Insufficient product identification information was provided and thus a risk management review could not be conducted.A clinical review states the literature article was reviewed.The images provided in the article have been interpreted within the text; therefore, no further analysis of the images is required.Without clinically relevant patient-specific supporting documentation, a thorough medical investigation could not be performed.The root cause of the subluxation and/or patient outcome beyond that which was documented in the article could not be confirmed nor concluded; therefore, no further medical assessment is warranted at this time.Should additional medical information be provided this complaint will be re-assessed.There was no relationship found between the device and the reported event.The complaint was not confirmed.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: 12895068
• Report Number: 1643264-2021-02443
• Device Sequence Number: 19760008
• Product Code: GAT
• UDI-Device Identifier: 03596010511942
• UDI-Public: 03596010511942
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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): 11/23/2022

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: 11/22/2022
• Initial Report FDA Received Date: 11/30/2021
• Supplement Report FDA Received Date: 11/23/2022
• 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