MAUDE Adverse Event Report: ALTO DEVELOPMENT CORPORATION MYO/WIRE II; DOUBLE WIRE STERNOTOMY SUTURE

Model Number	046-367
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	05/17/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device history record indicated that packaging was completed appropriately.No changes in personnel, equipment or process were identified.Records indicate that all appropriate seal checks were completed.Lot passed qc final inspection without issue.Complainant received 2 of 10 boxes in the complaint lot.There were no complaints from the other 5 customers who received product from the lot.All product was shipped in january and all but one of the 6 customers have reordered (including complainant) indicating that remaining product was used without an issue.Based on this, it is concluded that the one open unit was an isolated part.An internal capa has been opened to address manufacturing controls relative to the pouch sealing operation.
Event or Problem Description
Customer returned product because they found the product pouch (sterile barrier) to be unsealed.No patient was involved, open seal was noted during preparation for procedure.

• Brand Name: MYO/WIRE II
• Common Device Name: DOUBLE WIRE STERNOTOMY SUTURE
• Manufacturer (Section D): ALTO DEVELOPMENT CORPORATION; 5206 asbury road; farmingdale NJ 07727
• MDR Report Key: 5729204
• Report Number: 2242056-2016-00005
• Device Sequence Number: 45465
• Product Code: GAO
• UDI-Device Identifier: 10841291103882
• UDI-Public: 10841291103882
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K932513
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/16/2016

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: Nurse
• Device Expiration Date: 10/01/2020
• Device Model Number: 046-367
• Device Catalogue Number: 046-367
• Device Lot Number: 0573S
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/23/2016
• Initial Report FDA Received Date: 06/16/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other