MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC; INSTRUMENT, BENDING OR CONTOURING

Catalog Number 8114505

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/01/2015

Event Type  Injury  

Event Description

It was reported that, patient underwent a plif at l3 to l5.At the time of bending a multi-span plate with a pair of plate bender, one of plate benders was broken at the tip.The physician continued plate bending procedure with the same bender and the surgery was successfully completed.As a result of the incident, the surgical time was extended less than 15 minutes.The breakage occurred while the physician applied the force to bend the plate.After the incident, the dimple located near the grip end was used instead of the broken part.The fragment remained in the patient¿s body.However, no health damage was reported.The product was not used in the patient.

Manufacturer Narrative

(b)(4): the device has been returned to the manufacturer for evaluation.Analysis results are not available at the time of this report.A follow-up report will be sent when the analysis is complete.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Product analysis observations:a corner on the sleeved end of the bender has broken off.Microscopic review reveals a fairly brittle fracture that appears to emanate from the inside of the bender.The fracture face is consistent with that of sudden overload and not fatigue.Conclusion: the above observations are consistent with material overload.

Manufacturer Narrative

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

• Type of Device: INSTRUMENT, BENDING OR CONTOURING
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer (Section G): MEDTRONIC SOFAMOR DANEK; 1800 pyramid place; memphis TN 38132
• Manufacturer Contact: greg anglin ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 4870569
• MDR Text Key: 6264925
• Report Number: 1030489-2015-01305
• Device Sequence Number: 1
• Product Code: HXP
• 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: Foreign,Health Professional,Company Representative,company representati
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 08/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8114505
• Device Lot Number: NM12F004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/17/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/14/2013
• 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