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

Model Number	89070
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product involved in the event is not available for evaluation.O&m halyard, inc.Is the specification developer and complaint handling establishment of the halyard shoulder arthroscopy drape.The complaint component halyard shoulder arthroscopy drape, part number 89070 is contract manufactured by (b)(4) (fda registration number (b)(4)).Supplier corrective action request (scar) was submitted to the manufacturer on march 23, 2026.A follow-up report will be provided upon conclusion of investigation and response by the contract 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 an o&m halyard, inc.Product is defective or has caused serious injury.
Event or Problem Description
The drape fabric tore during the procedure; however, no injury was reported.The customer indicated the surgeon applied adhesive tape to the tear and proceeded with the operation.The damaged portion of the drape did not come into contact with the surgical site, and no delay in the procedure occurred.
Additional Manufacturer Narrative
Lianyungang aiyeh non-woven products co., ltd., supplier conducted an investigation based on the provided defect photos, which showed tearing in the instrument pad area.The supplier performed simulation testing and found that forceful pulling in both the cross direction (cd) and machine direction (md) did not result in tearing of the instrument pad.As the conditions during use are unknown, a definitive root cause could not be determined.This represents the first complaint of this nature and is considered an isolated incident.This product incident is documented in the o&m halyard, inc.Complaint database and identified as (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 an o&m halyard, inc.Product is defective or has caused serious injury.

• Brand Name: HALYARD SHOULDER ARTHROSCOPY DRAPE
• Common Device Name: SURGICAL DRAPES AND PACKS
• Manufacturer (Section D): O&M HALYARD, INC.; 1220 alpharetta rd.; ste 320; alpharetta GA 30005
• Manufacturer (Section G): LIANYUNGANG AIYEH NON-WOVEN PRODUCTS CO., LTD; no. 9 yunyang rd; pilot free trade zone; lianyungang jiangsu, china
• Manufacturer Contact: nichole coggins ; 1220 old alpharetta rd; ste 320; alpharetta, GA 30005 ; 8287820529
• MDR Report Key: 24798254
• Report Number: 3014421917-2026-00005
• Device Sequence Number: 9944068
• Product Code: PUI
• UDI-Device Identifier: 30680651890703
• UDI-Public: 30680651890703
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 04/22/2026

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: 89070
• Device Catalogue Number: 89070
• Device Lot Number: CA25352XXX
• 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: 03/23/2026
• Supplement Date Received by Manufacturer: 04/21/2026
• Initial Report FDA Received Date: 04/07/2026
• Supplement Report FDA Received Date: 04/22/2026
• 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