MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC RETRACTOR

Catalog Number 897-405

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 07/16/2019

Event Type  Injury  

Manufacturer Narrative

X-ray review results: intra-op film for l5 s1 alif show a retained fragment of one of the stability pins.It is unknown if it was able to be removed.Product was not returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient underwent anterior lumbar interbody fusion (alif) at l5-s1 due to degenerative disc.Intra-op, stability pin was broken off during retraction and point of stability pin stuck at l5-s1 right side of the patient.Fragment of the instrument remaining in the patient body.No sharp edges pointing true the bone, so risk to damage soft tissue.No revision surgery is planned to remove the broken part from the patient surgery.No patient's complications were reported as a results of this event.

Manufacturer Narrative

Product analysis results: visual inspection confirmed the pin was returned with approximately 14mm of the tip missing.A microscopic review of the fracture surface reveals a fairly steep angulation with a sheer lip at the end of the fracture.There did not appear to be any abnormalities at the crack initiation point that would have lead to this failure.The diameter of the shaft meets print specification.This type of damage is consistent with bend stress overload.If information is provided in the future, a supplemental report will be issued.

• Brand Name: RETRACTOR
• Type of Device: RETRACTOR
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer (Section G): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer Contact: stacie ziemba ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 8893478
• MDR Text Key: 154292669
• Report Number: 1030489-2019-00896
• Device Sequence Number: 1
• Product Code: GAD
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 897-405
• Device Lot Number: NG14D011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/27/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/06/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 40 YR