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

Catalog Number	OM-8175
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that during a primary rotator cuff repair, when the surgeon was deploying suture passer, the suture deployment failed and the plastic tip of the suture cartridge fell off into shoulder joint.The surgeon spent ten minutes attempting to retrieve cartridge tip, however it was then lost inside joint and could not be found again.A backup device was available to complete the procedure.Patient injuries were not reported.
Additional Manufacturer Narrative
The reported smartstitch perfectpasser suture cartridge, intended for use in treatment, was returned for evaluation.A relationship between the device and reported incident was not established.From the information provided, ¿during a primary rotator cuff repair, when the surgeon was deploying suture passer, the suture deployment failed and the plastic tip of the suture cartridge fell off into shoulder joint.The surgeon spent ten minutes attempting to retrieve cartridge tip, however it was then lost inside joint and could not be found again.¿ customer¿s complaint was not confirmed.Visual evaluation shows the suture cartridge returned is missing the tip.The device is intended for single use and functional test is not possible.An exact root cause cannot be determined with confidence; however, factors that could have contributed to the reported event include: excessive force or incorrect suture cartridge loading.The instruction for use was reviewed and found to outline precautionary statements and instructions in regards to the use of the device to avoid damage or non-functionality.There were no indications during manufacturing record review that would suggest that the device did not meet product specifications upon release into distribution.

• 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: 8952932
• Report Number: 3006524618-2019-00430
• Device Sequence Number: 2099922
• Product Code: GAT
• UDI-Device Identifier: 00817470005806
• UDI-Public: 00817470005806
• Combination Product (Y/N): N
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/14/2019

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: 06/30/2021
• Device Catalogue Number: OM-8175
• Device Lot Number: 2016724
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2019
• Initial Date Received by Manufacturer: 08/19/2019
• Supplement Date Received by Manufacturer: 11/13/2019
• Initial Report FDA Received Date: 09/01/2019
• Supplement Report FDA Received Date: 11/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1