MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH CONF INTRO NDLE, DIA, 11G 6"; NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE

Model Number	283903611
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/04/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The 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
I attend vertebroplasty surgery with the confidence system.When the needles references 283903611 were removed, after 8 min after mixing, one of them fractures at the rate of the pedicle and the fragment was not recovered.Surgeon reports that there is no problem but observed the weakness of the cannulas to dense bone rotation, since these were inserted with a lot of impact.Two needles of different lot were used and were not marked, i return both and their boxes.Attached photo of how it is in the pedicle and the boxes that remain in container.Procedure: vertebroplasty.This complaint involves one (1) device.
Additional Manufacturer Narrative
Product complaint # (b)(4).Udi: (b)(4).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.Upon visual inspection, it is observed that the hallow needle of the confidence cement introducer got broken midway.The broken fragment was not retrieved.The needle was observed to be filled with the bone cement.The rest of the device shows normal wear which would not contribute to the complaint condition.A manufacturing related potential cause was not suspected nor identified, therefore, no manufacturing record evaluation is required.While a definitive root cause could not be determined, it is possible that the device might have encountered unintended forces.No product design or manufacturing issues were identified, and no new malfunctions were identified either.Based upon these results, 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.
Additional Manufacturer Narrative
(b)(4).

• Brand Name: CONF INTRO NDLE, DIA, 11G 6"
• Common Device Name: NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 9124011
• Report Number: 1526439-2019-52162
• Device Sequence Number: 16778558
• Product Code: GAA
• UDI-Device Identifier: 10705034209494
• UDI-Public: (01)10705034209494
• Combination Product (Y/N): N
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/04/2019

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 Expiration Date: 03/31/2024
• Device Model Number: 283903611
• Device Catalogue Number: 283903611
• Device Lot Number: 241472
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2019
• Initial Date Received by Manufacturer: 09/04/2019
• Supplement Date Received by Manufacturer: 11/04/2019; 11/25/2019
• Initial Report FDA Received Date: 09/26/2019
• Supplement Report FDA Received Date: 11/20/2019; 11/26/2019
• 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: Other