MAUDE Adverse Event Report: HENRY SCHEIN, INC. HENRY SCHEIN; 101-1582

Model Number	101-1582
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/07/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on our review of the device history record (dhr) for the subject device, there were no recorded nonconformances, deviations, or other manufacturing anomalies that could account for the reported failure.All production and inspection processes were completed in accordance with specified requirements, and no irregularities were identified that would have impacted the device's functionality or quality.A total of (b)(4) samples were received with their original packaging, fully sealed and unopened, and were subjected to evaluation.All samples were tested using the needle pull test in accordance with applicable procedures.The results were successful, as none of the samples failed, and all met the established acceptance criteria.Based on the evaluation results, no evidence of needle detachment was identified.Therefore, the reported failure mode of needle detachment could not be confirmed, and the complaint is not confirmed.Based on the available information, no direct causal relationship to the manufacturing process can be established, and the potential root causes remain inconclusive due to the lack of supporting evidence.Review of labeling: contraindications this suture, being absorbable, should not be used where extended approximation of tissue is required.The use of this suture is contraindicated in patients with known sensitivities or allergies to collagen or chromium, as gut is a collagen based material, and chromic gut is treated with chromic salt solutions.Warnings do not resterilize, discard open, unused sutures and associated surgical needles.Users should be familiar with surgical wound closure, as the risk of wound dehiscence may vary with the site of application and the suture material used.Physicians should consider the in vivo performance (under actions section) when selecting for use in patients.The use of this suture may be inappropriate in elderly, malnourished, or debilitated patients, or in patients suffering from conditions which may delay wound healing.As with any foreign body, prolonged contact of any suture with salt solutions, such as those found in the urinary or biliary tracts, may result in calculi formation.As an absorbable suture, gut may act transiently as a foreign body.Acceptable surgical practice should be followed for the management of contaminated or infected wounds.As this is an absorbable material, the use of supplemental nonabsorbable sutures should be considered by the surgeon in the closure of sites which may undergo expansion, stretching or distention or which may require additional support.Certain patients may be hypersensitive to collagen or chromium and might exhibit an immunological inflammation, tissue granulation or fibrosis, wound suppuration and bleeding, as well as sinus formation.Precautions: care should be taken to avoid damage when handling.Avoid crushing or crimping the suture material with surgical instruments, such as needle holders and forceps.Infections, erythema, foreign body reactions, transient inflammatory reactions and in rare instances wound dehiscence are typical or foreseeable risks associated with any suture and hence are also potential complications associated with gut suture.The surgeon should avoid unnecessary tension when running down knots, to reduce the occurrence of surface fraying and weakening of the strand under some circumstances, notably orthopaedic procedures, immobilization of joints by external support may be employed at the discretion of the surgeon.Avoid prolonged exposure to elevated temperatures.To avoid damaging needle points and swage areas.Grasp the needle in an area one-third (1/3) to one-half (1/2) of the distance from the swaged end to the point.Reshaping needles may cause them to lose strength and be less resistant to bending and breaking.Users should exercise caution when handling surgical needles to avoid inadvertent needle sticks.Discard used needles in sharps containers.Adverse reactions: adverse effects associated with the use of this device may include: wound dehiscence; variable rates of absorption over time (depending on the type of suture used, the presence of infection and tissue site); failure to provide adequate wound support in closure of sites where expansion.Stretching or distension occur, etc., unless additional support is supplied through the use of nonabsorbable suture material: failure to provide adequate wound support in elderly, malnourished.Or debilitated patients or in patients suffering from conditions which may delay wound healing: allergic response in patients with known sensitivities to collagen or chromium which may result in an immunological reaction resulting in inflammation, tissue granulation or fibrosis, wound suppuration and bleeding as well as sinus formation; infection: moderate tissue inflammatory response characteristic of foreign body response; calculi formation in urinary and biliary tracts when prolonged contact with salt solutions such as urine and bile occurs: and transitory local irritation at the wound site.Broken needles may result in extended or contaminated surgical needles may result in the transmission of blood borne pathogens.
Event or Problem Description
It was reported on 24 march 2026 that during use the needle detached, fell into the patient and was retrieved.No injuries reported.

• Brand Name: HENRY SCHEIN
• Common Device Name: 101-1582
• Manufacturer (Section D): HENRY SCHEIN, INC.; 135 duryea road; melville NY
• Manufacturer (Section G): SURGICAL SPECIALTIES MÉXICO, S. DE R.L. DE C.V.; corredor tijuana-rosarito 2000; no. 24702-b; tijuana, b.c. 22235 ; MX 22235
• Manufacturer Contact: virnalisa cobacha ; 2755 canyon boulevard; 1st floor; boulder, CO 80302
• MDR Report Key: 24806157
• Report Number: 3010692967-2026-00015
• Device Sequence Number: 9620675
• Product Code: GAL
• UDI-Device Identifier: 00304040000250
• UDI-Public: 00304040000250
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K896554
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/07/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 101-1582
• Device Lot Number: F825KJT
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/25/2025
• 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
• Patient Sex: Unknown