MAUDE Adverse Event Report: A&E MEDICAL CORPORATION A&E SINGLE WIRE STERNUM SUTURES; STERNOTOMY SUTURE

Model Number	046-093
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/02/2021
Type of Reportable Event	Malfunction
Event or Problem Description
A customer reported that the sternum sutures they received had the incorrect needle type.Based on the part number, the needles should have been the blunt end needle type.However, the needles they received were sharp (cutting edge needle type).The products were not used and there was no patient injury.
Additional Manufacturer Narrative
The devices with the incorrect needle configuration were not used, and therefore there was no patient injury.Additionally, no additional complaints have been received for this lot.Replacement parts have been provided to the customer.An image of the devices showing the incorrect needle type was provided by the reporter, confirming that the parts had sharp needles instead of the blunt end needles.The device history records for the reported lot were reviewed and it was found that the incorrect needle was staged during manufacturing and therefore the incorrect needle was swaged onto the wire.Product from the same lot that was still in stock at a&e was checked, and it was found that some of the sutures had the incorrect needles; all parts from the lot were quarantined and scrapped.Further investigation into this issue is currently being conducted.A closure report will be submitted once investigation and any measures to address the issue are complete.
Additional Manufacturer Narrative
The picture provided by the customer of the product, as well as visual inspection of the returned product, confirmed that the needles on the sutures were sharp instead of blunt.A review of the complaint history in the past 24 months from the date of this complaint revealed no similar complaints to this issue.Upon receipt of this complaint, a non-conformance report was opened.The investigation found that the incorrect needles (cutting edge style) were staged during manufacturing and therefore the incorrect needle was swaged onto the wire.The complaint product (b)(4), lot 03361 (manufacture date 22apr2021-04jun2021) was manufactured with subassembly sa-046-090, lots 03370 and 02987 (staging material included 83 from lot 02987, 2077 from 03370).The specification for sa-046-090 requires the needle to be either 1170046a or 1170048a which are stainless steel, curved, taper point blunt end needles with drill end for suture attachment.Subassembly sa-046-090, lot 03370 (manufacture date 04may2021) was manufactured with needle 1170043a which is a stainless steel, curved, cutting edge needle with drill end for suture attachment.There were 30 boxes manufactured for the complaint product.27 out of 30 were in stock at a&e and were checked and it was found that some of the sutures had the incorrect needles; all parts from the lot were quarantined and scrapped.An event analysis was conducted, and the following causes were identified as contributing to this failure: incorrect needle was staged.Verification of material was ineffective.Packaging team did not realize that the needle was incorrect since they were using the correct suture.As a corrective action, a&e's line clearance procedure lcp1001 was updated to add visual aids in the appendices for needle verification.At the start of a new job, production personnel must now refer to the appendices to verify that the correct needle is issued to the job.Production personnel were also made aware of this complaint and trained on this procedure.Given that this is an isolated incident, and there have been no other similar complaints, no further actions are required.
Event or Problem Description
A customer reported that the sternum sutures they recieved had the incorrect needle type.Based on the part number, the needles should have been the blunt end needle type.However, the needles they recieved were sharp (cutting edge needle type).The products were not used and there was no patient injury.

• Brand Name: A&E SINGLE WIRE STERNUM SUTURES
• Common Device Name: STERNOTOMY SUTURE
• Manufacturer (Section D): A&E MEDICAL CORPORATION; 5206 asbury road; farmingdale NJ 07727
• Manufacturer (Section G): A&E MEDICAL COPORATION; 5206 asbury road; farmingdale NJ 07727
• Manufacturer Contact: vashina shukla ; 5206 asbury road; farmingdale,, NJ 07727 ; 7329387337
• MDR Report Key: 12408424
• Report Number: 2242056-2021-00006
• Device Sequence Number: 3245496
• Product Code: GAO
• UDI-Device Identifier: 20841291103476
• UDI-Public: (01)20841291103476(10)03361(17)260401
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: K932513
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/30/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/01/2026
• Device Model Number: 046-093
• Device Lot Number: 03361
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/02/2021
• Supplement Date Received by Manufacturer: 08/02/2021
• Initial Report FDA Received Date: 09/01/2021
• Supplement Report FDA Received Date: 08/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/04/2021
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown