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

Catalog Number	OM-8175
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/17/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Foreign zip code: (b)(6).
Event or Problem Description
It was reported that during an arthroscopic rotator cuff repair, a perfect passer magnum wire suture was applied into the tendon.After the device was used it was noticed that the end part of the device was broken and was missing.Potential that the tip was left in the tendon.Patient injuries were not reported.
Additional Manufacturer Narrative
Additional information added.
Event or Problem Description
It was reported that during an arthroscopic rotator cuff repair, a perfect passer magnum wire suture was applied into the tendon.After the device was used it was noticed that the end part of the device was broken and was missing.The consultant had a good look around the shoulder joint for the broken piece but couldn¿t find it within the joint and was satisfied that the broken piece was not in the joint. the issue did not cause any delay in the procedure and it was successfully completed with the same device.No additional treatment or x-ray was carried out at the time.
Additional Manufacturer Narrative
The reported smartstitch perfectpasser suture cartridge, 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 an arthroscopic rotator cuff repair, a perfect passer magnum wire suture was applied into the tendon.After the device was used it was noticed that the end part of the device was broken and was missing.Potential that the tip was left in the tendon.¿ 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 needle and/or suture (2) excessive force.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.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.When loading a suture cartridge, be sure not to kink the suture tube.Kinking the suture tube may cause a malfunction during application of the suture.Ensure that the suture cartridge is locked to the distal tip of the suturing device.Tug gently but firmly to assure secure placement.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: 8643278
• Report Number: 3006524618-2019-00251
• Device Sequence Number: 11217936
• Product Code: GAT
• UDI-Device Identifier: 00817470005806
• UDI-Public: 00817470005806
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K123268
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/30/2019

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: 09/01/2021
• Device Catalogue Number: OM-8175
• Device Lot Number: 2019527
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/09/2019
• Supplement Date Received by Manufacturer: 08/26/2019; 08/30/2019
• Initial Report FDA Received Date: 05/26/2019
• Supplement Report FDA Received Date: 08/27/2019; 08/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1