MAUDE Adverse Event Report: CLASSIC WIRE CUT CO, INC. SPECTRUM AUTOPASS NEEDLE, QTY 5; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number SMI-02N

Device Problem Material Fragmentation (1261)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/02/2023

Event Type  malfunction  

Manufacturer Narrative

The device is not expected to be returned for evaluation and review.However, the complaint investigation is not complete at this time.A supplemental and final report will be filed following the completion of the complaint investigation.We will continue to monitor for trends through the complaint system to assure patient safety.

Event Description

The distributor reported on behalf of their customer that the smi-02ap, spectrum autopass suture passer, was being used during a shoulder scope procedure on (b)(6) 2023 when it was reported, ¿the instrument was broken during the surgery.¿ there was no report of injury, medical intervention, or hospitalization for the patient or user.Further assessment questions found that the suture passer device had not broken, but yet, the needle used with the device had broken and fell to the floor.The reporter has not identified the needle that was used with the suture passer; therefore, smi-02n, spectrum autopass needle, qty 5, was chosen to represent that device.The procedure was reported as having been completed as planned using an alternate same-like device.There was no report of delay in the procedure.The smi-02ap, spectrum autopass suture passer device will be listed as the concomitant device.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.

Manufacturer Narrative

The device will not be returned, and no photographic evidence was provided.Therefore, the reported event cannot be verified.The manufacturing documents from the device history record have not been reviewed because the lot number is not known.The lot history review was not conducted because the lot number is not known.(b)(4).Per the instructions for use, the user is advised the following: if the suture passer needle kinks during use, immediately discontinue use and discard.There is an increased risk of needle breakage and unintentional patient injury may result.Do not use disposable suture passer needle for more than one (1) procedure.Reuse could cause fatigue and/or breakage of the needle, which may cause possible patient injury.We will continue to monitor for trends through the complaint system to assure patient safety.

Event Description

The distributor reported on behalf of their customer that the smi-02ap, spectrum autopass suture passer, was being used during a shoulder scope procedure on (b)(6) 2023 when it was reported, ¿the instrument was broken during the surgery.¿ there was no report of injury, medical intervention, or hospitalization for the patient or user.Further assessment questions found that the suture passer device had not broken, but yet, the needle used with the device had broken and fell to the floor.The reporter has not identified the needle that was used with the suture passer; therefore, smi-02n, spectrum autopass needle, qty 5, was chosen to represent that device.The procedure was reported as having been completed as planned using an alternate same-like device.There was no report of delay in the procedure.The smi-02ap, spectrum autopass suture passer device will be listed as the concomitant device.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.

• Brand Name: SPECTRUM AUTOPASS NEEDLE, QTY 5
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): CLASSIC WIRE CUT CO, INC.; 25014 anza drive; valencia CA 91355
• Manufacturer (Section G): CLASSIC WIRE CUT CO, INC.; 25014 anza drive; valencia CA 91355
• Manufacturer Contact: john berga ; 11311 concept blvd; largo, FL 33773 ; 7273995358
• MDR Report Key: 16884899
• MDR Text Key: 314745010
• Report Number: 1017294-2023-00040
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Reporter Country Code: JO
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SMI-02N
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SMI-02AP, SPECTRUM AUTOPASS SUTURE PASSER; SMI-02AP, SPECTRUM AUTOPASS SUTURE PASSER
• Patient Age: 38 YR
• Patient Sex: Female
• Patient Weight: 80 KG
• Patient Ethnicity: Non Hispanic