MAUDE Adverse Event Report: DEPUY SYNTHES SPINE SI POLYAXL SCREW 7 X 40MM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Catalog Number	179712740
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Spinal Column Injury (2081)
Date of Event	01/01/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).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
Two expedium si screw head breakage at level s1 (exact size of screw unknown - acc.To pictures app.6 x 40 mm).Occured at unknown date app.One year after initial surgery (unknwon date).Screw breakage was noticed during revision surgery on (b)(6) 2017.Patient consequence: no.Is the information being submitted for this complaint all the details that are known/available regarding this event: yes.
Additional Manufacturer Narrative
Product complaint # (b)(4).Visual examination at the macroscopic level revealed the sample was fractured in the neck region of the screw shank.The shank components were not returned for analysis.Optical images of the fractured surfaces exhibit two surface morphologies, smooth regions and grainy/rough regions with progression lines which are indicative of fatigue failure.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.A trend analysis was conducted.No emerging trends were found requiring further actions.With the information provided, a definitive root cause cannot be determined.However, fracture analysis suggests fatigue failure, fracture being initiated at one end and propagating to full breakage.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.
Additional Manufacturer Narrative
(b)(4).

• Brand Name: SI POLYAXL SCREW 7 X 40MM
• Common Device Name: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
• Manufacturer (Section D): DEPUY SYNTHES SPINE; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7069464
• Report Number: 1526439-2017-50015
• Device Sequence Number: 127212
• Product Code: NKB
• UDI-Device Identifier: 10705034067728
• UDI-Public: 10705034067728
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K160904
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/02/2017

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 Catalogue Number: 179712740
• Device Lot Number: ATJDTP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2017
• Initial Date Received by Manufacturer: 11/02/2017
• Supplement Date Received by Manufacturer: 12/06/2017; 01/16/2018
• Initial Report FDA Received Date: 11/29/2017
• Supplement Report FDA Received Date: 12/06/2017; 01/22/2018
• 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
• Patient Age: 64 YR