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

Model Number	72203841
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Injury (2348)
Date of Event	08/28/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that after surgery on (b)(6) 2019 patient started with neuropraxia and pain, therefore he was treated with medication therapy and hospitalization was prolonged and he was discharged the following day.The issue was solved with sequelae.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
H10: h6: the reported suturefix ultra anr xl, used in treatment, will not be returned for evaluation.The investigation was limited to the information provided.The investigation could not draw any conclusions about the reported event.Without the relevant clinical information a thorough medical investigation cannot be rendered, should any additional medical information be provide this complaint will be re-assessed.The instruction for use outlines precautionary statements and instructions in regards to the use of the device to avoid damage or non-functionality.A review of the risk document, manufacturing and complaint records was performed for the reported lot, there were no indications that would suggest that the device did not meet product specifications upon release into distribution.
Additional Manufacturer Narrative
H11: e1: update initial reporter information.G3: update country.(b)(6).

• 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: 9588434
• Report Number: 1219602-2020-00088
• Device Sequence Number: 3337404
• Product Code: MBI
• UDI-Device Identifier: 00885554030051
• UDI-Public: 00885554030051
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/08/2020

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/25/2024
• Device Model Number: 72203841
• Device Catalogue Number: 72203841
• Device Lot Number: 2025373
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/23/2019
• Supplement Date Received by Manufacturer: 01/16/2020; 02/27/2020
• Initial Report FDA Received Date: 01/14/2020
• Supplement Report FDA Received Date: 01/17/2020; 03/08/2020
• 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
• Patient Age: 42 YR