MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH 5.5 EXP VERSE FEN SCR 6.0X30; BONE CEMENT, POSTERIOR SCREW AUGMENTATION

Model Number	199723630
Medical Device Problem Code	Torn Material (3024)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	03/07/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).One (1) expedium verse fenestrated screw was returned for evaluation.Visual examination at the macroscopic level revealed that the sample fractured on one of the top notches.The fractured component was not returned for analysis.The optical image of the fractured surface exhibits a flat surface with torsional shear marks along the length of the fracture.This is consistent with a torsional shear overload failure.Additional damage was observed on the threads of the intact top-notch feature.A device history record review did not identify any issues that could have cause or contributed to the reported event.All complaint trends will be evaluated as a part of the depuy spine monthly complaint review meeting.A definitive root cause of the fenestrated screw being broken cannot be determined from the sample and the information provided.However, fracture analysis of the screw suggests the damage is consistent with a torsional shear overload failure.No issues were identified in the manufacturing and release of this device that could have contributed to the problem reported by the customer.A such, the complaint will be closed with no further action required.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
L4-s1 posterolateral fusion (b)(6) private hospital (b)(6) 2018.Three x screws were placed on the left side at l4/5/s1 and the rods and correction keys had also been placed and final tightened.During the final step of breaking off the extended tabs of the left l5 verse screw one tab broke below the indicated breaking point.In doing so the correction key was no longer retaining the rod securely within the head of the screw.The surgeon removed the other 2 x correction keys at l4 and s1 and rod from the left side construct to allow him to remove the left l5 verse pedical screw.Surgeon then replaced a new screw, rod and correction keys and again final tightened the construct.The breaking of the tabs was then successful and operation was completed.Surgeon happy with end result of the operation.Ten minutes delay to procedure, no ae to patient male patient (b)(6).

• Brand Name: 5.5 EXP VERSE FEN SCR 6.0X30
• Common Device Name: BONE CEMENT, POSTERIOR SCREW AUGMENTATION
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 7463939
• Report Number: 1526439-2018-50406
• Device Sequence Number: 18868342
• Product Code: PML
• UDI-Device Identifier: 10705034403113
• UDI-Public: (01)10705034403113
• Combination Product (Y/N): N
• PMA/510(K) Number: K160879
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 199723630
• Device Catalogue Number: 199723630
• Device Lot Number: ATJD9L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2018
• Initial Date Received by Manufacturer: 03/27/2018
• Initial Report FDA Received Date: 04/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention