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

Catalog Number 8796003

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/09/2016

Event Type  malfunction  

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.

Event Description

It was reported that on (b)(6) 2016, patient presented with pre-op diagnosis: herniation.For which patient underwent anterior fusion at level c3-c4-c5.Intra-op, the prefixation pin inserted in the hole of caudal side was broken during removal.After placement of plate, pins were inserted at the cranial and the caudal sides under surgical technique.The pin was inserted by hammering because the patient¿s bone was hard.The fluoroscopic image revealed that the pin that was inserted at caudal side remained a little bent.The pin was broken during pulling out so the placed plate was removed once and the pin was removed using hospital¿s device.After that, the plate was placed again and four screws were inserted and then the surgery was finished.The pin was completely removed, and no fragment remained in the patient¿s body.There was no patient complication as a result of this event.Doctor's comment: it occurred possibly because of hammering.

Manufacturer Narrative

Product analysis: microscopic examination appears to show fairly ductile fracture.Microscopic examination appears to show helical fracture with circular material flow with shaft angulation, suggesting torsional overload with bending component.The above observations are consistent with torsional overload.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.

Manufacturer Narrative

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

• Brand Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Type of Device: PIN, FIXATION, SMOOTH
• 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: greg anglin ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 6140430
• MDR Text Key: 61549999
• Report Number: 1030489-2016-03321
• Device Sequence Number: 1
• Product Code: HTY
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 01/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8796003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/09/2016
• Initial Date FDA Received: 12/01/2016
• Supplement Dates Manufacturer Received: Not provided; 01/19/2017
• Supplement Dates FDA Received: 02/13/2017; 09/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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