MAUDE Adverse Event Report: DAVIS & GECK CARIBE LTD UNKNOWN MONOSOF SUTURE; SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE

Model Number UNKNOWN MONOSOF SUTURE

Device Problems Difficult to Remove (1528); Detachment of Device or Device Component (2907)

Patient Problems Nerve Damage (1979); Unintended Radiation Exposure (4565); Insufficient Information (4580)

Event Date 09/30/2021

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, the needle detached from the suture and into wound bed.

Event Description

According to the reporter, during a suturing of hand laceration, while using the device in the soft tissue in hand, the needle detached from the suture, fell into wound bed, and embedded into tissue.The needle was unable to be initially removed in the emergency room.The patient¿s hand was sutured up with needle in wound bed and was referred to a hand specialist.The patient had to have an outpatient hand surgery with a hand specialist to remove needle from soft tissue.X-ray was performed.The surgical time was extended by more than 30 minutes.The patient stated that she had possible nerve damage, and needed to go to outpatient rehab per hand specialists.

Manufacturer Narrative

New information has been received pertaining to the event.This event has been reassessed and the reportability has been determined to be a serious injury.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: UNKNOWN MONOSOF SUTURE
• Type of Device: SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE
• Manufacturer (Section D): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 0101 ; DR 0101
• Manufacturer (Section G): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 0101 ; DR 0101
• Manufacturer Contact: tracy landers ; 5920 longbow drive; boulder, CO 80301 ; 3035816943
• MDR Report Key: 12775886
• MDR Text Key: 280949321
• Report Number: 9612501-2021-01840
• Device Sequence Number: 1
• Product Code: GAR
• 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,User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 11/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN MONOSOF SUTURE
• Device Catalogue Number: UNKNOWN MONOSOF SUTURE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/22/2021
• Initial Date FDA Received: 11/08/2021
• Supplement Dates Manufacturer Received: 11/12/2021
• Supplement Dates FDA Received: 11/29/2021
• 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): Required Intervention
• Patient Age: 53 YR
• Patient Sex: Female