MAUDE Adverse Event Report: ARTHROCARE CORP. SMARTSTITCH PERFECTPASSER SUTURE CARTRID; SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE

Model Number	OM-8176
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Foreign zipcode: (b)(6).
Event or Problem Description
It was reported that during a bankart intervention a patient with instability of the left shoulder was scheduled to be intervened with a smartstitch perfectpasser suture cartridge equipment had been made by the hospital.Once the patient was asleep, and the procedure started, it was noticed by the surgeon that the suture cartridge was not the right one.The surgeon decided to stop the procedure.Due to this cancellation it was not reported any injury or damage to patient.Same procedure with the correct cartridge was scheduled six days later and it was successfully completed.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
One om-8176 smartstitch perfect passer suture cartridge reported on was not used for treatment and was not returned for evaluation.A second complaint was opened for the same procedure, same situation.The surgical procedure was scheduled with reservation of speedlock and speedstich equipment but a smartstitch suture cartridge was made available.Smartstitch, speedlock and speedstitch products were acceptable individually but not used since the components were incompatible with each other.The complaint is not functional or damage related, but ordering related.The surgery was ceased and rescheduled using speedlock and speedstich product.The sales rep was then present and provided the list of references to send when booking speedlock/speedstich to avoid further mistakes in the future.Per ifu: ¿the smartstitch¿ suturing device handle is a reusable device designed for use with a smartstitch connector and smartstitch suture cartridge for placing suture through soft tissue.¿ (as is speedlock, speedstitch is intended for use with speedlock, speedstitch).It was not reported who ordered or provided the incompatible cartridges.No valid lot number provided.Complaint review was completed.Product met specifications upon release to distribution.No further investigation is warranted at this time.
Additional Manufacturer Narrative
The reported device, used in treatment, was not returned for evaluation.A relationship between the product and reported incident cannot be established as the product was not returned.Complaint history review for part number om-8176 the previous 36 months and failures related to ¿suture cartridge was not the right one¿ issue found 0 (zero) similar complaints.Dhr/ batch record review is not possible as the device lot number is not available at this time.Without the reported product a fully visual and functional evaluation cannot be performed and customer¿s complaint cannot be confirmed.An exact root cause cannot be determined without evaluation of the device; however, factors unrelated to the manufacture or design of the device that could have contributed to the reported event include: (1) incorrect suture cartridge.No containment or corrective actions are recommended at this time.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.
Additional Manufacturer Narrative
The initial incident report was submitted with incorrect manufacturing site information and registration number (b)(6).The correct manufacturing site information and registration number is (b)(6).Corrected data: d3 and g1 manufacturing site name and address information.

• Brand Name: SMARTSTITCH PERFECTPASSER SUTURE CARTRID
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• MDR Report Key: 9270727
• Report Number: 1219602-2019-01366
• Device Sequence Number: 2409033
• Product Code: GAT
• UDI-Device Identifier: 00817470005820
• UDI-Public: 00817470005820
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K123268
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/27/2020

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: OM-8176
• Device Catalogue Number: OM-8176
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/10/2019
• Supplement Date Received by Manufacturer: 12/17/2019; 02/08/2020; 02/12/2020
• Initial Report FDA Received Date: 11/03/2019
• Supplement Report FDA Received Date: 12/27/2019; 02/08/2020; 02/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 30 YR