MAUDE Adverse Event Report: ARTHROCARE CORP. SPEEDSTITCH DEVICE; SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE

Model Number	OM-7000
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Information (3190)
Date of Event	09/27/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during surgery, when the surgeon was using the speedstitch gun for capsule closure in the hip and upon removing the device from the patient the shaft of the speedstitch device would pull off and remain in the cannula.The surgeon would just grab the piece sticking out of cannula and remove by hand.A backup device was available to complete the procedure with no significant delay or other complications.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Event or Problem Description
It was reported that during hip arthroscopy, when the surgeon was using the speedstitch gun for capsule closure and upon removing the device from the patient, the shaft of the speedstitch broke and disassembled from hand piece and remained in the cannula.The surgeon would just grab the piece sticking out of cannula and removed it by hand.A backup device was available to complete the procedure with no significant delay or other complications.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
H10 h3, h6: the device, used in treatment, was returned for evaluation.There was a relationship found between the returned device and the reported incident.A review of the device history records for the device showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review concluded this was a repeat issue.A review of the instructions for use found statements related to complaint event.A review of risk management files found that the reported failure was documented appropriately.Visual inspection of the device revealed that the barrel is completely detached from handle.The tube is bent.Functional evaluation revealed that the device was unable to be functionally tested due to the bent tube.The complaint was verified as the device's barrel was detached.Factors, which may have contributed to the reported complaint include: 1) excessive force.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.

• Brand Name: SPEEDSTITCH DEVICE
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• MDR Report Key: 10717541
• Report Number: 3006524618-2020-00903
• Device Sequence Number: 3345724
• Product Code: GAT
• UDI-Device Identifier: 00817470001402
• UDI-Public: 00817470001402
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K042031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: OM-7000
• Device Catalogue Number: OM-7000
• Device Lot Number: H107550
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2020
• Initial Date Received by Manufacturer: 09/27/2020
• Supplement Date Received by Manufacturer: 10/20/2020; 11/25/2020
• Initial Report FDA Received Date: 10/22/2020
• Supplement Report FDA Received Date: 11/10/2020; 12/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention