MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH EXP DI POLYAXL SCRW 6 X 40MM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Model Number	179722640
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Spinal Column Injury (2081)
Date of Event	05/21/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is available for evaluation.Investigation will be conducted.Follow up will be filed with the investigation results.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
The broken screw was discovered during the spine revision surgery ¿ the removal of n expedium construct from levels th11 to s1, in which the broken pin was implanted in level l1 (and the l2 vertebra had a pre-primary surgery fracture ¿ there were no screws inserted in vertebral body).
Additional Manufacturer Narrative
(b)(4).Visual examination at the macroscopic level reveals that the fracture occurred in the neck region of the screw shank.Device was then sent for fracture analysis.The fracture analysis report reveals evident fatigue striations/progression lines that extend across the surfaces toward the potential crack termination site.A review of the device history record was conducted.No issues were identified during the manufacturing and release of this product that could have contributed to the problem reported by the customer.All complaint trends will be evaluated as a part of the depuy spine monthly complaint review meeting.A definitive root cause for the polyaxial screw fracturing cannot be positively determined.However, the fracture analysis report reveals evident fatigue striations/progression lines that extend across the surfaces toward the potential crack termination site.As there has been no issue identified in the manufacturing or release of the device that could have contributed to the problem reported by the customer and no systemic trends were found, this complaint file 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.

• Brand Name: EXP DI POLYAXL SCRW 6 X 40MM
• Common Device Name: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 7601279
• Report Number: 1526439-2018-50556
• Device Sequence Number: 16492895
• Product Code: NKB
• UDI-Device Identifier: 10705034070629
• UDI-Public: (01)10705034070629
• Combination Product (Y/N): N
• Initial Reporter Country: SI
• PMA/510(K) Number: K160904
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/21/2018

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: 179722640
• Device Catalogue Number: 179722640
• Device Lot Number: ATCBTF
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2018
• Initial Date Received by Manufacturer: 05/21/2018
• Supplement Date Received by Manufacturer: 07/13/2018
• Initial Report FDA Received Date: 06/14/2018
• Supplement Report FDA Received Date: 07/19/2018
• 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