MAUDE Adverse Event Report: SEQUEL SPECIAL PRODUCTS ULTRAFIX MICROMITE STITCHPAK, SUTURE ANCHOR; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number	10301
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Date of Event	06/23/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is not expected to be returned for evaluation and review.However, the complaint investigation is not complete at this time.A supplemental and final report will be filed following the completion of the complaint investigation.We will continue to monitor for trends through the complaint system to assure patient safety.
Event or Problem Description
The customer reported that the 10301, ultrafix micromite stitchpak, suture anchor device was being used during a left thumb ulnar collateral ligament repair procedure on (b)(6) 2023 date when it was reported post operatively ¿patient had a ucl on her thumb in august and she was quite satisfied with her results.However, 8 weeks after the surgery, she started getting bumps similar to pimples and that they turned into pox-like lesions that soon erupted.She said that now 90% of her body is covered with these pox-like bumps and open sore.They are causing her pain and unbearable itching.She has gone to the doctor and the surgery center to try to find out what the issue is, but doesn¿t feel like they are taking her seriously.During her pre-surgery appointment, she said she made sure the dr knew of her autoimmune issues and that she was also allergic to nickel.The dr office (i believe) told her that the anchor used was the linvatec mighy mite.She has been to the er because this reaction is affecting her breathing¿.Further assessment questioning found that ¿ surgical site prepped with hibiclens and alcohol.There are no current plans to remove the implant from the patient.The patient did not report a nickel allergy to the facility and it was not documented on her history and physical from her pcp.There are no photos available of the patient's reaction.¿.It was also reported that the patient has the following additional allergies ¿vp dye, cipro, amoxicillin/penicillin, aspirin, nsaids, oxycodone, sulfa, latex, dextromethorpan, adhesive tapes, contrast dye.Vancomycin.¿.The procedure was completed, and no medical intervention or extended hospitalization was required.This report is being raised on the reported injury due to patient obtaining an allergic reaction.
Event or Problem Description
The customer reported that the 10301, ultrafix micromite stitchpak, suture anchor device was being used during a left thumb ulnar collateral ligament repair procedure on (b)(6) 2023 date when it was reported post operatively ¿patient had a ucl on her thumb in (b)(6) and she was quite satisfied with her results.However, 8 weeks after the surgery, she started getting bumps similar to pimples and that they turned into pox-like lesions that soon erupted.She said that now 90% of her body is covered with these pox-like bumps and open sore.They are causing her pain and unbearable itching.She has gone to the doctor and the surgery center to try to find out what the issue is, but doesn¿t feel like they are taking her seriously.During her pre-surgery appointment, she said she made sure the dr knew of her autoimmune issues and that she was also allergic to nickel.The dr office (i believe) told her that the anchor used was the linvatec mighy mite.She has been to the er because this reaction is affecting her breathing¿.Further assessment questioning found that ¿ surgical site prepped with hibiclens and alcohol.There are no current plans to remove the implant from the patient.The patient did not report a nickel allergy to the facility and it was not documented on her history and physical from her pcp.There are no photos available of the patient's reaction.¿.It was also reported that the patient has the following additional allergies ¿vp dye, cipro, amoxicillin/penicillin, aspirin, nsaids, oxycodone, sulfa, latex, dextromethorpan, adhesive tapes, contrast dye.Vancomycin.¿.The procedure was completed, and no medical intervention or extended hospitalization was required.This report is being raised on the reported injury due to patient obtaining an allergic reaction.
Additional Manufacturer Narrative
The device will not be returned, and no photographic evidence was provided.Therefore, the reported event cannot be verified the manufacturing documents from the device history record have been reviewed with special attention to the manufacturing and inspection of the product.The product released for distribution was found to have met all specifications prior to shipment.This is the only complaint for this lot number and failure mode within the past two years.A two-year review of complaint history revealed there has been a total of 1 complaint, regarding 1 device, for this device family and failure mode.During this same time frame 6,048 devices have been manufactured and shipped worldwide.Should all the complaint devices have been found confirmed for this reported failure, the rate of failure would be 0.0002.Per the instructions for use, the user is advised that foreign body sensitivity - where material sensitivity is suspected, appropriate tests should be made and sensitivity ruled out prior to implantation.All implant devices used for these surgical procedures should have the same chemical composition.This will reduce the possibility of galvanic corrosion or other metallic reactions.Preoperative and operating procedures including knowledge of surgical techniques and proper selection and placement of the implant are important considerations in the successful utilization of this device.We will continue to monitor for trends through the complaint system to assure patient safety.

• Brand Name: ULTRAFIX MICROMITE STITCHPAK, SUTURE ANCHOR
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SEQUEL SPECIAL PRODUCTS; 1 hillside dr.; wolcott CT 06716
• Manufacturer (Section G): SEQUEL SPECIAL PRODUCTS; 1 hillside dr.; wolcott CT
• Manufacturer Contact: samantha dewberry ; 525 french road; utica, NY 13502 ; 3152230184
• MDR Report Key: 18257907
• Report Number: 1017294-2023-00111
• Device Sequence Number: 20798203
• Product Code: MBI
• UDI-Device Identifier: 10845854040331
• UDI-Public: (01)10845854040331(17)271215(30)1(10)34922
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K981764
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/10/2024

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 Catalogue Number: 10301
• Device Lot Number: 34922
• 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: 11/07/2023
• Supplement Date Received by Manufacturer: 12/20/2023
• Initial Report FDA Received Date: 12/04/2023
• Supplement Report FDA Received Date: 01/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 52 YR
• Patient Sex: Female
• Patient Weight: 123 KG
• Patient Ethnicity: Non Hispanic