MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC MANUAL ORTHOPEDIC SURGICAL INSTRUMENT; PROBE

Catalog Number 803-290

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 08/04/2017

Event Type  Injury  

Manufacturer Narrative

Product was not returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.Product image review: submitted images appear to display instrument tip broken off.

Event Description

It was reported that intra-op, the probe at 20 mm from the distal portion snapped off and remained in patient's illiac crest.Fragment could not be removed as it could cause additional trauma to the patient.No revision surgery is planned.No patient complications were reported as a result of the event.

Manufacturer Narrative

X ray image review: intra-op films show a retained fragment of a holt probe which fractured during placement of an iliac screw.The likely cause of this is operator use.The small fragment within the bone should have a low likelihood of migration or neurological injury.Bio-compatibility of the material to implantation needs to be examined further.If information is provided in the future, a supplemental report will be issued.

• Brand Name: MANUAL ORTHOPEDIC SURGICAL INSTRUMENT
• Type of Device: PROBE
• 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: 6833451
• MDR Text Key: 84074084
• Report Number: 1030489-2017-01980
• Device Sequence Number: 1
• Product Code: HXB
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 803-290
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/13/2017
• Was Device Evaluated by Manufacturer?: No
• 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: 71 YR