MAUDE Adverse Event Report: ASPEN SURGICAL PRODUCTS, CALEDONIA NEEDLE 1/2 CIRCLE TAPER POINT INTESTINAL, .024X.748, STERILE; SURGICAL NEEDLE

Model Number 212905

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 05/28/2019

Event Type  Injury  

Manufacturer Narrative

Aspen surgical received a letter from the fda (mw5086893) indicating that a needle broke during a procedure.Incident occurred at the end user.Manufacturing lot number was provided for review.Medwatch letter indicated the following, "needle used during orthopedic surgery, tip broke off into bone.Surgeon used product during orthopedic surgery.Bit broke off in bone and tech noticed it.Surgeon was then notified." no additional information was provided.No customer information was provided.A review of the device history record was completed.No non-conformance's were noted relating to the reported issue.No further information is available on the product.Based on this information, the root cause can not be established and no further action is required.Device not available.

Event Description

Aspen surgical received a letter from the fda (mw5086893) indicating that a needle broke during a procedure.Incident occurred at the end user.This report was filed in our complaint handling system as complaint # (b)(4).

• Brand Name: NEEDLE 1/2 CIRCLE TAPER POINT INTESTINAL, .024X.748, STERILE
• Type of Device: SURGICAL NEEDLE
• Manufacturer (Section D): ASPEN SURGICAL PRODUCTS, CALEDONIA; 6945 southbelt dr. s.e.; caledonia MI 49316
• Manufacturer (Section G): SAME AS ABOVE
• Manufacturer Contact: jordan hackert ; 6945 southbelt dr. s.e.; caledonia, MI 49316 ; 6165367508
• MDR Report Key: 8749813
• MDR Text Key: 149687210
• Report Number: 1836161-2019-00052
• Device Sequence Number: 1
• Product Code: GAB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 212905
• Device Lot Number: 145457
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/06/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/24/2017
• 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 Outcome(s): Other; Required Intervention