MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH SI POLYAXL EXT TAB 7 X 50MM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Model Number	179732750
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint #: (b)(4).Additional pro-codes: mnh, kwp, nkb, kwq, mni.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.Device was used for treatment, not diagnosis.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
It was reported that on (b)(6) 2021, the si polyaxl ext tab 7 x 50mm was broken during reverse logistics audit of returned device at (b)(4).There was no patient involvement and no additional information is available.Concomitant product: si polyaxl ext tab 7 x 50mm.This complaint involves one (1) si polyaxl ext tab 7 x 50mm.This report is1 of 1 for (b)(4).
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H3, h4, h6: the dhr of product code 179732750, lot argb1b, was reviewed and no non-conformances were observed during the manufacturing process.The product was released on may 14, 2014.Qty.96.The dhr was electronically reviewed.Visual inspection: the si polyaxl ext tab 7 x 50mm(product code 179732750, lot argb1b) was received at us customer quality (cq).Upon visual inspection it was noticed that the screw shank component was broken below the head and the reduction tabs were broken the broken components were not returned.No other defects was identified on the device.Defect identified? yes.Dimensional inspection: no dimensional analysis was performed due to confirmed post manufacturing damage identified.Complaint confirmed? yes.Conclusion: the complaint condition is confirmed.No definitive root cause could be determined based on the provided information.No new, unique or different patient harms were identified as a result of this evaluation.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: SI POLYAXL EXT TAB 7 X 50MM
• Common Device Name: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 11379517
• Report Number: 1526439-2021-00360
• Device Sequence Number: 17090333
• Product Code: MNI
• UDI-Device Identifier: 10705034074054
• UDI-Public: (01)10705034074054
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K160904
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/03/2021

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: Health Professional
• Device Model Number: 179732750
• Device Catalogue Number: 179732750
• Device Lot Number: ARGB1B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2021
• Initial Date Received by Manufacturer: 02/03/2021
• Supplement Date Received by Manufacturer: 03/12/2021
• Initial Report FDA Received Date: 02/25/2021
• Supplement Report FDA Received Date: 03/24/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SI POLYAXL EXT TAB 7 X 50MM.; SI POLYAXL EXT TAB 7 X 50MM