MAUDE Adverse Event Report: ARTHROCARE CORP. SMARSTITCH PP MW BLACK COBRAID; SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE

Catalog Number	OM-8177
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/25/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Foreign zip code: (b)(6).
Event or Problem Description
It was reported that during a rotator cuff repair upon passing the suture through the rotator cuff the suture cartridge snapped.When pulling out, the sutures had not been passed through.The procedure was completed with a backup device with no significant delay or patient injury reported.No pieces were lost inside the patient.
Additional Manufacturer Narrative
The reported smartstitch perfect passer magnum wire black cobraid device, intended for use in treatment, was not returned for evaluation.A relationship between the product and reported incident cannot be established as the product was not returned.Without the reported product a visual and functional evaluation cannot be performed and customer¿s complaint cannot be confirmed.From the information provided, ¿during a rotator cuff repair upon passing the suture through the rotator cuff the suture cartridge snapped.When pulling out, the sutures had not been passed through.¿ 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 loading.(2) damaged suture cartridge.(3) crushing or crimping damage due to application of surgical instruments can result in failure.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.The instruction for use states: -in handling this or any other suture material, care should be taken to avoid damage from handling.Avoid crushing or crimping damage due to application of surgical instruments such as forceps or needle holders.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: SMARSTITCH PP MW BLACK COBRAID
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• MDR Report Key: 8628760
• Report Number: 3006524618-2019-00245
• Device Sequence Number: 16599653
• Product Code: GAT
• UDI-Device Identifier: 00817470001112
• UDI-Public: 00817470001112
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• 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): 06/28/2019

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: 01/31/2020
• Device Catalogue Number: OM-8177
• Device Lot Number: 1181674
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/20/2019
• Supplement Date Received by Manufacturer: 06/27/2019
• Initial Report FDA Received Date: 05/21/2019
• Supplement Report FDA Received Date: 06/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1