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 09/30/2021

Event Type  malfunction  

Event Description

On behalf of the facility, the distributor in (b)(4) reported issues with the spectrum autopass suture passer item # smi-02ap, sn # (b)(4), and smi-02n lot 60694, that gestion access sante inc.Recently experienced on (b)(6) 2021.Information received indicated that during a rotator cuff repair procedure involving a (b)(6) patient, (b)(6), the smi-02ap had a needle that broke into it.It happened once and the second one also had similar issues, but we do not think there is a broken needle in it." it is indicated there was no patient impact /injury and the procedure was completed with a 2minute delay by using another device.Additional information received notes that when jaw breaks apart, the surgeon grabs the jaw part that falls in the shoulder and takes it out.Both the smi-02aps and smi-02n needle broke apart when grasping the rotator cuff.All pieces were removed and there is no impact or injury to the patient.No piece of the broken needle fell off into the patient.Each device will be reported to the fda on separate mdr filings.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence as the device jaw broke in the patient¿s shoulder and was removed.

Manufacturer Narrative

At time of filing, although expected, the reported device has not been received into conmed¿s complaint system for evaluation.A supplemental and final report will be filed following the completion of the device evaluation and complaint investigation.This issue will continue to be monitored through the complaint system to assure patient safety.

Event Description

On behalf of the facility, the distributor in canada reported issues with the spectrum autopass suture passer item # smi-02ap, sn # (b)(6) & sn # (b)(6), and smi-02n lot 60694, that gestion access sante inc.Recently experienced on 30sept2021.Information received indicated that during a rotator cuff repair procedure involving a 56yr old patient, weighing 90kg., the smi-02ap had a needle that broke into it.It happened once and the second one also had similar issues, but we do not think there is a broken needle in it." it is indicated there was no patient impact /injury and the procedure was completed with a 2minute delay by using another device.Additional information received notes that when jaw breaks apart, the surgeon grabs the jaw part that falls in the shoulder and takes it out.Both the smi-02aps and smi-02n needle broke apart when grasping the rotator cuff.All pieces were removed and there is no impact or injury to the patient.No piece of the broken needle fell off into the patient.Each device will be reported to the fda on separate mdr filings.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence as the device jaw broke in the patient¿s shoulder and was removed.

Manufacturer Narrative

Investigation of the customer's reported event of ¿needle broke in it¿ is confirmed.The evaluation of the returned suture passer found the needle was broken inside the device.The returned device exhibits the reported claim however a root cause cannot be established.A 2year lot history review was conducted per process and found this is the only event with a quantity of 6 units for this lot number and failure mode however, only 1 unit was confirmed.A dhr review performed by the vendor found a quantity of 2,025 units were manufactured; date of manufacture is 12-apr-2021.A two-year review of complaint history revealed there has been a total of 9 complaints, regarding 14 devices, for this device family and failure mode.During this same time frame 39,799 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.The instructions for use (ifu) provides the user with information regarding proper care and use of this device.Also, per the ifu, the user is advised to avoid lateral stresses to the instrument or device function may be compromised.Prior to use, inspect instrument to ensure it is in good physical condition and functions properly.There should be no loose, broken or misaligned parts.Avoid mechanical shock or over stressing the instrument which may shorten the life if the instrument.This issue will continue to be monitored through the complaint system to assure patient safety.

• Brand Name: SPECTRUM AUTOPASS NEEDLE, QTY 5
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): CLASSIC WIRE CUT CO. INC.; 28210 constellation road; valencia CA 91355
• Manufacturer (Section G): CLASSIC WIRE CUT CO. INC.; 28210 constellation road; valencia CA 91355
• Manufacturer Contact: tracey weiselbenton ; conmed corporation; 11311 concept blvd; largo, FL 33773 ; 7273995557
• MDR Report Key: 12715583
• MDR Text Key: 282573232
• Report Number: 1017294-2021-00350
• 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,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/13/2021

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
• Device Operator: Health Professional
• Device Catalogue Number: SMI-02N
• Device Lot Number: 60694
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2021
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/01/2021
• Initial Date FDA Received: 10/28/2021
• Supplement Dates Manufacturer Received: 11/22/2021
• Supplement Dates FDA Received: 12/13/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/12/2021
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Age: 56 YR
• Patient Weight: 90 KG
• Patient Ethnicity: Non Hispanic