MAUDE Adverse Event Report: TIDI PRODUCTS LLC C-ARMOR DRAPE; C-ARMOR DRAPES CLEAR POLYETHYLENE STERILE UNIVERSAL FIT

Model Number	5523
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
We're an orthopedic surgery center here in (b)(6).We've been purchasing the c-armor drape (5523) with mckesson.I just wanted to make you guys aware that we had a hole in the drape that we opened today.Lot # 030764.I asked the surgical tech that was in that case and she said it has never happened before and she feels like it was made that way (no cut in the outer packaging).We haven't had another one yet but i'll be sure to let you know if we have another.(emails from customer).
Additional Manufacturer Narrative
Pui is the product code for this device, however, it was not available in the product code drop down during submission of the report.The complaint product is not available to be returned for evaluation.Therefore, this report is based on customer-provided information only.The device history record for this lot was reviewed and identified no nonconformances or other failures documented that could have contributed to the reported issue.All samples passed inspection prior to release.Historical complaint data review identified no other complaints for this failure mode for this device, or any other skus in this product family, documented in the last 5 years.There have been no related nonconformances documented at the manufacturing site in the last 2 years.This appears to be an isolated incident.At this time, there is not enough evidence to confirm that a manufacturing non-conformity contributed to the reported complaint.The manufacturing site has been notified of the complaint.No further corrective or preventative actions are necessary.All complaints are trended and reviewed by management on a monthly basis.As part of this monthly review, any excursion above the control limits for this failure mode will be assessed, documented and acted upon as warrant.Manufacturer reference file (b)(4).

• Brand Name: C-ARMOR DRAPE
• Common Device Name: C-ARMOR DRAPES CLEAR POLYETHYLENE STERILE UNIVERSAL FIT
• Manufacturer (Section D): TIDI PRODUCTS LLC; 570 enterprise drive; neenah WI 54956
• Manufacturer Contact: chris rahn ; 570 enterprise drive; neenah, WI 54956 ; 9207514300
• MDR Report Key: 15765372
• Report Number: 2182318-2022-00129
• Device Sequence Number: 12321900
• Product Code: KKX
• UDI-Device Identifier: 00618125140152
• UDI-Public: 00618125140152
• Combination Product (Y/N): N
• 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: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/12/2022

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
• Device Model Number: 5523
• Device Catalogue Number: 5523
• Device Lot Number: 030764
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/12/2022
• Initial Report FDA Received Date: 11/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/28/2022
• Is the Device Labeled for Single Use? (Y/N): No
• 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