MAUDE Adverse Event Report: STRYKER SPINE-FRANCE MANTIS REDUX REDUCTION SCREW 7.5 X 45MM; PEDICLE SCREW SPINAL SYSTEM

Model Number	48289745
Medical Device Problem Codes	Fracture (1260); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/17/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that : "mounting l5-s1, inserting screws*, pedicular sight with square point, pedicle probe, palpator.Insert the screw with the redux screwdriver.Installation of the rod and nut.When inserting the nut into the l5 screw head then inserting the nut into the screw head in s1.On the left side, when the nut is inserted into the screw head in s1, the screw thread has "fouled".The surgeon tried to change the nut and insert the new nut into the screw head.By breaking the fins in s1, the surgeon noticed that the nut was not holding; the screw thread has "cracked" under the reduction thread.The surgeon therefore removed the nut in l5, then the stem to replace the screw in s1.* during the l5 pedicle sighting, the instrumentalist has mounted the screw on the redux screwdriver, the arms, redux vis dia.7.5 x 45 mm, sterile: 1 unit.Consequently, the instrumentalist used a new redux screw, surgical delay of 30 min".
Additional Manufacturer Narrative
Method: visual inspection; device history review; complaint history review; risk assessment.Results: no relevant manufacturing issues were identified as all units met specifications.The device was inspected, and deformation was visible in the threading of the tabs attached to the tulip head.Conclusion: the most likely cause of the reported event was determined to be user error.
Event or Problem Description
It was reported that : "mounting l5-s1, inserting screws*, pedicular sight with square point, pedicle probe, palpator.Insert the screw with the redux screwdriver.Installation of the rod and nut.When inserting the nut into the l5 screw head then inserting the nut into the screw head in s1.On the left side, when the nut is inserted into the screw head in s1, the screw thread has "fouled".The surgeon tried to change the nut and insert the new nut into the screw head.By breaking the fins in s1, the surgeon noticed that the nut was not holding; the screw thread has "cracked" under the reduction thread.The surgeon therefore removed the nut in l5, then the stem to replace the screw in s1.* during the l5 pedicle sighting, the instrumentalist has mounted the screw on the redux screwdriver, the arms, redux vis dia.7.5 x 45mm, sterile: 1 unit.Consequently, the instrumentalist used a new redux screw, surgical delay of 30 min".

• Brand Name: MANTIS REDUX REDUCTION SCREW 7.5 X 45MM
• Common Device Name: PEDICLE SCREW SPINAL SYSTEM
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 6483150
• Report Number: 0009617544-2017-00138
• Device Sequence Number: 11063301
• Product Code: MNH
• UDI-Device Identifier: 04546540671264
• UDI-Public: (01)04546540671264
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K102235
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/20/2017

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
• Operator of Device: No Information
• Device Model Number: 48289745
• Device Catalogue Number: 48289745
• Device Lot Number: 166959
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2017
• Initial Date Received by Manufacturer: 03/17/2017
• Supplement Date Received by Manufacturer: 03/17/2017
• Initial Report FDA Received Date: 04/11/2017
• Supplement Report FDA Received Date: 07/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1