MAUDE Adverse Event Report: O&M HALYARD, INC. HALYARD BASICS SHOULDER ARTHROSCOPY DRAPE 100 IN; SURGICAL DRAPES AND PACKS

Model Number	79758
Medical Device Problem Code	Material Disintegration (1177)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/14/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Concerns have been raised regarding the quality of the drapes, as they have been observed to deteriorate during use, resulting in fragments entering open shoulder wounds.The complainant has indicated that there was no medical intervention required and no patient injury.
Additional Manufacturer Narrative
The product involved in the event was not available for return.O&m halyard, inc.Is the specification developer and complaint handling establishment of the halyard basics shoulder arthroscopy drape 100 in.62 in.254 cm 157.The complaint component halyard basics shoulder arthroscopy drape 100 in.62 in.254 cm 157, part number 79758 is contract manufactured by gri medical & electronic technology co., ltd.(fda registration number 3004911384).A supplier corrective action (scar) was submitted to the manufacturer on january 19, 2026.A follow-up report will be provided upon conclusion of investigation and response by the manufacturer.This product incident is documented in the o&m halyard, inc.Complaint database and identified as complaint (b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that a o&m halyard, inc.Product is defective or has caused serious injury.
Additional Manufacturer Narrative
The complaint details were forwarded to the appropriate functional area for investigation and root cause determination.No complaint sample or supporting photographs were provided for evaluation.Visual inspection of the retained sample revealed no abnormalities, and a review of the production records identified no nonconformities; therefore, a root cause could not be determined.Production records confirmed that operators performed all manufacturing steps in accordance with approved work instructions and specifications.The process included pouching the sms material, applying double-sided tape, gluing the tube holder, and attaching the pouch to the sms material.No nonconformities were identified during these manufacturing steps.Quality inspections included visual examinations for loose material, tears, damage, and other potential defects.No nonconformities were observed during sampling inspection.A review of complaint history from january 2025 through january 2026 indicated this is the first complaint related to a surgical drape falling apart for products manufactured on the same production line.Based on the investigation results, no further actions are required at this time.This product incident is documented in the o&m halyard, inc.Complaint database and identified as complaint comp-(b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that a o&m halyard, inc.Product is defective or has caused serious injury.

• Brand Name: HALYARD BASICS SHOULDER ARTHROSCOPY DRAPE 100 IN
• Common Device Name: SURGICAL DRAPES AND PACKS
• Manufacturer (Section D): O&M HALYARD, INC.; 1220 old alpharetta rd; ste 320; alpharetta GA 30005
• Manufacturer (Section G): GRI MEDICAL & ELECTRONIC TECHNOLOGY CO., LTD.; 1805 honggao road; xiuzhou industry zone; jiaxing zhejiang, china
• Manufacturer Contact: nichole coggins ; 1220 old alpharetta rd; ste 320; alpharetta, GA 30005 ; 8287820529
• MDR Report Key: 24234235
• Report Number: 3014421917-2026-00003
• Device Sequence Number: 13057269
• Product Code: PUI
• UDI-Device Identifier: 30680651797583
• UDI-Public: 30680651797583
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/12/2026

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: 79758
• Device Catalogue Number: 79758
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/19/2026
• Supplement Date Received by Manufacturer: 02/10/2026
• Initial Report FDA Received Date: 02/02/2026
• Supplement Report FDA Received Date: 02/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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