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 02/15/2018

Event Type  Injury  

Manufacturer Narrative

Neither the device nor films of applicable imaging studies were 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 an unknown reason.Intra-op, endoring pin broke in the patient vertebra and screwing (threaded) part of the pin stayed into the patient (approx 1 cm).No patient complications were reported as a result of this event.Also, no additional surgery has been performed to remove the portion left inside the patient's body.

Manufacturer Narrative

Additional information: due to imdrf harmonization, some previously submitted device, method, result, and conclusion codes related to this event may have been updated.Product analysis result: visual microscopic dimensional the pin was returned with 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 and hardness of the pin were checked and meet print specification.The previous observations are consistent with bend stress overload.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

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: 7337820
• MDR Text Key: 102347055
• Report Number: 1030489-2018-00385
• Device Sequence Number: 1
• Product Code: GAD
• 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: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2018
• 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: NG14H021
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/27/2014
• 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: 68 YR
• Patient Weight: 74