MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH CONF INTRO NDLE, BEV, 13G 6"; NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE

Model Number	283902613
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2019
Type of Reportable Event	Malfunction
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
It was reported that the end of needle tore during use.No patient impact.Was surgery delayed due to the reported event? --> no, action taken when event occurred? --> new needle used, was procedure successfully completed? --> yes, were fragments generated? --> no, if yes, were they removed easily without additional intervention? --> unknown, patient status/ outcome / consequences --> no, was other medical intervention (e.G.X-rays, additional procedures, prescriptions, otc, revision) required: --> unknown, is the patient part of a clinical study --> unknown.
Additional Manufacturer Narrative
Product complaint # (b)(4).Visual examination of the returned needle featured a small section of its cannulated tip crumpled upwards along the beveled core and split along one side.This may have been the result of stress applied during insertion of the needle.A review of the device history record could not be performed since the lot number was not provided.Confidence kit parts do not feature their lot number on their surface.All complaint trends will be evaluated as a part of the depuy spine monthly complaint review meeting.The root cause of the needle tip becoming crimped and split cannot be determined from the samples and the information provided.A potential root cause may be inadvertently applying enough force on the tip of the needle to cause it to break in this manner.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
Product complaint #: (b)(4).

• Brand Name: CONF INTRO NDLE, BEV, 13G 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: 8408874
• Report Number: 1526439-2019-51435
• Device Sequence Number: 16221483
• Product Code: GAA
• UDI-Device Identifier: 10705034209449
• UDI-Public: (01)10705034209449
• 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): 02/19/2019

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: 283902613
• Device Catalogue Number: 283902613
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2019
• Initial Date Received by Manufacturer: 02/19/2019
• Supplement Date Received by Manufacturer: 04/05/2019; 05/07/2019
• Initial Report FDA Received Date: 03/11/2019
• Supplement Report FDA Received Date: 04/29/2019; 05/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1