MAUDE Adverse Event Report: CLASSIC WIRE CUT CO. INC. SPECTRUM AUTOPASS SUTURE PASSER; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number SMI-02AP

Device Problem Material Fragmentation (1261)

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

Event Date 09/30/2021

Event Type  malfunction  

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

Conmed (b)(4) received notice from the distributor of reported issues with the smi-02ap, spectrum autopass suture passer, sn # (b)(4), that was experienced on (b)(6) 2021.Information received indicated that during a rotator cuff repair procedure, the jaw of the smi-02ap lot 5153619 broke at the same place as it usually breaks.Additional information received notes that when jaw breaks apart, the surgeon grabs the jaw part that falls in the shoulder and takes it out.The smi-02ap breaks apart when grasping the rotator cuff.There is no impact or injury to the patient.The procedure was completed with a 2 minute delay by using an alternate device.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 complaint of ¿jaw broke¿ is confirmed.The returned, used device was evaluated per device designs and found the lower jaw is broken off with no other signs of damage.The mechanisms feel normal and there is no noticeable bend in the devices shaft.The needle loads into suture passer with no issue noted.The broken lower jaw was not returned for evaluation.The service history was reviewed, and no data was found.A review of the manufacturing documents from the device history record (dhr) performed by the vendor found a quantity of (b)(4)units were manufactured; date of manufacture is 15-mar-2019.A two-year review of complaint history revealed there has been a total of 37 complaints, regarding (b)(4) devices, for this device family and failure mode.During this same time frame (b)(4) 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 0.0009.As this is a reusable device, the potential number of uses is not considered in this failure rate.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.

Event Description

Conmed canada received notice from the distributor of reported issues with the smi-02ap, spectrum autopass suture passer, sn # (b)(6), that was experienced on 30sept2021.Information received indicated that during a rotator cuff repair procedure, the jaw of the smi-02ap lot 5153619 broke at the same place as it usually breaks.Additional information received notes that when jaw breaks apart, the surgeon grabs the jaw part that falls in the shoulder and takes it out.The smi-02ap breaks apart when grasping the rotator cuff.There is no impact or injury to the patient.The procedure was completed with a 2minute delay by using an alternate device.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.

• Brand Name: SPECTRUM AUTOPASS SUTURE PASSER
• 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: 12714219
• MDR Text Key: 281666393
• Report Number: 1017294-2021-00347
• 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: 12/09/2021

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-02AP
• Device Lot Number: 5153619
• 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: 12/09/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/15/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Patient Weight: 100 KG
• Patient Ethnicity: Non Hispanic