MAUDE Adverse Event Report: LAB MEDICAL MANUFACTURING INC SPECTRUM II HANDLE; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number C6350

Device Problem Material Fragmentation (1261)

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

Event Type  malfunction  

Event Description

The customer reported that the device, c6350, spectrum ii handle, was being used during an unknown procedure on an unknown date when it was reported ¿the spectrum handle ref.C6350 with the batch number 2015230 presented a problem during a surgery.The item broke in the patient's knee and then has been recovered.¿.Further information was requested of the reporter but to date no further information has been received.There was no report of injury, medical intervention, or extended hospitalization for the patient.This report is being raised on the reported malfunction with potential for injury upon reoccurrence.

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.

Manufacturer Narrative

The device will not be returned and no photographic evidence has been provided therefore the reported event cannot be verified the manufacturing documents from the device history record have been reviewed with special attention to the manufacturing and inspection of the product.The product released for distribution was found to have met all specifications prior to shipment.This is the only complaint for this lot number and failure mode within the past two years.A two-year review of complaint history revealed there has been a total of 16 complaints, regarding (b)(4) , 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 0.0003.Per the instructions for use, the user is advise if the hook or needle bends during use, immediately discontinue use and discard.There is an increased risk of hook or needle breakage and unintentional patient injury may result.Avoid lateral stresses to the instruments or device function may be compromised.There is an increased risk of hook or needle breakage and unintentional patient injury may result.Do not use if parts are broken, cracked or worn, or device function may be compromised.There is an increased risk of hook or needle breakage and unintentional patient injury may result.The information obtained does not reasonably suggest the device has or may have caused or contributed to a death, serious injury or has malfunctioned in a manner that would be likely to cause or contribute to a death or serious injury if it were to recur.We will continue to monitor for trends through the complaint system to assure patient safety.

Event Description

The customer reported that the device, (b)(4) , spectrum ii handle, was being used during an unknown procedure on an unknown date when it was reported ¿the spectrum handle ref.(b)(4) with the batch number 2015230 presented a problem during a surgery.The item broke in the patient's knee and then has been recovered.¿.Further information was requested of the reporter but to date no further information has been received.There was no report of injury, medical intervention, or extended hospitalization for the patient.This report is being raised on the reported malfunction with potential for injury upon reoccurrence.

• Brand Name: SPECTRUM II HANDLE
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): LAB MEDICAL MANUFACTURING INC; 28 cook street; billerica MA 01821
• Manufacturer (Section G): LAB MEDICAL MANUFACTURING INC; 28 cook st; billerica, MA 01821
• Manufacturer Contact: samantha dewberry ; 525 french road; utica, NY 13502 ; 3152230184
• MDR Report Key: 17878114
• MDR Text Key: 325009154
• Report Number: 1017294-2023-00092
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 11/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: C6350
• Device Lot Number: 2015230J
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/04/2015
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Ethnicity: Non Hispanic