MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH CONF INTRO NDLE, DIA, 11G 4"; NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE

Model Number	283903411
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	06/28/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).A complaint investigation will be performed.The complaint product is not available for the investigation.A supplemental report is not anticipated unless the results of the complaint investigation identify a corrective action or additional relevant information.Should the product become available, a physical evaluation will be conducted and a supplemental report filed with the 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
Rupture of the needle as it has been reported in the attached operating report.(see additional information for translation) the lot of the damaged needle is not know with certainly because during surgical procedure has been used two different lots: 1 piece of lot 205607 deadline:07/31/2023, 4 pieces of lot 228932 deadline:12/31/2023.This complaint involves five (5) devices.
Additional Manufacturer Narrative
Product complaint#: (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.Investigation summary: the conf intro ndle, dia, 11g 4" [product code: 2839-03-411, lot number: 205607] was not returned to the customer quality unit for evaluation.It was noted that the customer retained the device.Therefore, the reported device failure cannot be confirmed as no device has been returned for evaluation.Thus, an investigation will be based on a no sample device evaluation.Should more information and/or the device sample become available at a later date, this complaint file will be reopened and the device will then receive a full evaluation.The device history record (dhr) for the conf intro ndle, dia, 11g 4" [product code: 283903411, lot: 205607] was reviewed electronically and no non-conformances were observed during the manufacturing process.As a result, the dhr identified no issues during the manufacturing and release of this device 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.Without the return of the device we are unable to confirm the reported issue or identify the root cause.No corrective action/preventive action (capa) is necessary at this time as no issues were identified in the manufacturing and release of this device.Therefore, this complaint file will be closed with no further action required.Should more information and/or the device sample become available at a later date, this complaint file will be reopened, and the device will then receive a full evaluation.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: CONF INTRO NDLE, DIA, 11G 4"
• 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: 8889124
• Report Number: 1526439-2019-51966
• Device Sequence Number: 14081963
• Product Code: GAA
• UDI-Device Identifier: 10705034209456
• UDI-Public: (01)10705034209456
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/26/2019

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: 07/31/2023
• Device Model Number: 283903411
• Device Catalogue Number: 283903411
• Device Lot Number: 205607
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/26/2019
• Supplement Date Received by Manufacturer: 10/22/2019
• Initial Report FDA Received Date: 08/13/2019
• Supplement Report FDA Received Date: 10/23/2019
• 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: Required Intervention
• Patient Age: 25 YR