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

Catalog Number SMI-02D

Device Problem Material Fragmentation (1261)

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

Event Date 06/23/2023

Event Type  malfunction  

Event Description

The sales representative reported on behalf of the customer that the smi-02d, spectrum autopass needle was being used on (b)(6) 2023 during a rotator cuff repair procedure and ¿spectrum autopass disposable needle broke in patient¿.There was no impact or injury to the patient.The procedure was completed with an alternate same device.There was a five minute delay to the procedure.Per assessment it was found, the device did fragment and fall into the surgical site.All fragments were retrieved.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.

Manufacturer Narrative

The reported device is being returned to conmed for evaluation.A supplemental and final report will be filed following the completion of the device evaluation and complaint investigation.We will continue to monitor for trends through the complaint system to assure patient safety.H3 other text : device not yet received.

Manufacturer Narrative

The device has not been returned for evaluation to date and no photographic evidence was provided therefore the reported event could not be verified.If the device is returned, the investigation may be updated and reanalyzed.A 2 year lot history review could not be conducted as a lot number was not provided.A device history record review could not be conducted as a lot number was not provided.A two-year review of complaint history revealed there has been a total of 18 reports, regarding 23 devices, for this device family and failure mode.During this same time frame 51,634 devices have been manufactured and shipped worldwide.Should all the complaint devices have been found confirmed for this reported failure, the rate of failure would be 0.0004.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 sales representative reported on behalf of the customer that the smi-02d, spectrum autopass needle was being used on (b)(6) 2023 during a rotator cuff repair procedure and ¿spectrum autopass disposeable needle broke in patient¿.There was no impact or injury to the patient.The procedure was completed with an alternate same device.There was a five minute delay to the procedure.Per assessment it was found, the device did fragment and fall into the surgical site.All fragments were retrieved.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: robin drum ; 11311 concept blvd.; largo, FL 33773 ; 8653881978
• MDR Report Key: 17277994
• MDR Text Key: 318779718
• Report Number: 1017294-2023-00061
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SMI-02D
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/28/2023
• 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
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic