MAUDE Adverse Event Report: AVID MEDICAL, INC. LIFENET BONE RECOVERY PACK; LIFENET BONE RECOVERY PACK #2

Model Number	LIFE0166
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	05/02/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Incident one: during the donation harvesting process, the bag used for holding collected tissue tore.The donated tissue was deemed a loss for the intended recipient.The status of intended recipient is unknown as the customer was unable to provide details following inquiries on (b)(6) 2024, (b)(6) 2024 and (b)(6) 2024.
Additional Manufacturer Narrative
Incident one.The product involved in the event was not returned for evaluation.A follow-up report will be provided upon conclusion of investigation.This product incident is documented in the 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 product is defective or has caused serious injury.
Additional Manufacturer Narrative
***correction - degage corporation added to all manufacturers section*** incident one.The complaint bag was manufactured by degage corp.The supplier has performed an investigation confirming machine had no issues during manufacture and confirmed all preventive maintenance was completed, in-process production and quality reports completed were found to be conforming.During review of all documentation, the supplier did discover a first article inspection report was not completed prior to production, potentially contributing to issue.Quality control inspector was retrained.This product incident is documented in the 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 product is defective or has caused serious injury.

• Brand Name: LIFENET BONE RECOVERY PACK
• Common Device Name: LIFENET BONE RECOVERY PACK #2
• Manufacturer (Section D): AVID MEDICAL, INC.; 9000 westmont drive; toano VA 23168
• Manufacturer (Section G): DEGAGE CORPORATION; po box 1599; terrell TX 75160
• Manufacturer Contact: nichole coggins ; 9000 westmont drive; toano, VA 23168 ; 8287820529
• MDR Report Key: 20396084
• Report Number: 1047429-2024-00003
• Device Sequence Number: 7944143
• Product Code: LRO
• UDI-Device Identifier: 10809160369531
• UDI-Public: 10809160369531
• 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): N
• 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): 11/22/2024

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: LIFE0166
• Device Catalogue Number: LIFE0166
• Device Lot Number: 1585237
• 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: 09/12/2024
• Supplement Date Received by Manufacturer: 10/31/2024
• Initial Report FDA Received Date: 10/08/2024
• Supplement Report FDA Received Date: 11/22/2024
• 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