MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TRUEPASS SUTURE PASSER SELF-CAPTURE; ACCESSORIES,ARTHROSCOPIC

Model Number	72203791
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/14/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that, during a demonstration, the spring on the top of the head in the "truepass suture passer (self-capture)" jumped out and damaged.No case reported; therefore, there was no patient involvement.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 reported device, intended for use in treatment, was received for evaluation.There was a relationship found between the returned device and the reported incident.An analysis of the customer provided images identified the spring as the torsion spring on the suture capture door.It had dislodged from the top jaw and was poking out of the device.A visual inspection revealed that the device was returned with a tip protector present.The torsion spring of the suture capture door had dislodged.It was bent out of alignment with its shaft and pointing up.The other springs on the device were standard.There was no obvious debris.A review of the device records 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.The complaint was confirmed and the root cause was associated with component failure.Factors that could have contributed to the reported event include forceful replacement of the tip protector, excessive pulling on the suture capture door, or wear over time.

• Brand Name: TRUEPASS SUTURE PASSER SELF-CAPTURE
• Common Device Name: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 11113722
• Report Number: 1219602-2021-00019
• Device Sequence Number: 1059836
• Product Code: NBH
• UDI-Device Identifier: 00885554030419
• UDI-Public: 00885554030419
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: EXEMPT
• 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
• Report Date (Section B): 02/06/2021

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: 72203791
• Device Catalogue Number: 72203791
• Device Lot Number: 56126
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2021
• Initial Date Received by Manufacturer: 12/15/2020
• Supplement Date Received by Manufacturer: 02/04/2021
• Initial Report FDA Received Date: 01/04/2021
• Supplement Report FDA Received Date: 02/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1