MAUDE Adverse Event Report: DEPUY SPINE INC CONF INTRO NDLE, DIA, 13G 4"; NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE

Model Number	283903413
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/13/2019
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
It was reported that on unknown date, during an unknown procedure the tip broke off at the beginning of the pedicle while inserting the needle without initiated excessive force.It is unknown if there was no surgical delay.Patient status is unknown.This complaint involves one (1) device.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
Product complaint # = > (b)(4).Visual examination of the device revealed that the needle had broken at the distal end of the cannula.The other half of the cannula was not returned.The distal section of the cannulated needle features some deformed sections, indicating that it may have bent or been compacted due to forces on it during use.A review of the device history record (dhr) could not be performed since the lot number was not provided.Confidence kit products do not have their lot numbers printed or etched directly on their surface, though the kit¿s box features the lot number on its label.Without the lot number, no review of its manufacturing records could be completed.The root cause of the cannula breaking cannot be determined from the sample and the information provided.A potential root cause may be accidentally placing significant forces on the cannula during its use in the patient.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, 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.

• Brand Name: CONF INTRO NDLE, DIA, 13G 4"
• Common Device Name: NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8668274
• Report Number: 1526439-2019-51724
• Device Sequence Number: 2207406
• Product Code: GAA
• UDI-Device Identifier: 10705034209463
• UDI-Public: (01)10705034209463
• 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: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/13/2019

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 Model Number: 283903413
• Device Catalogue Number: 283903413
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2019
• Initial Date Received by Manufacturer: 05/13/2019
• Supplement Date Received by Manufacturer: 08/02/2019; 08/22/2019; 09/04/2019
• Initial Report FDA Received Date: 06/04/2019
• Supplement Report FDA Received Date: 08/20/2019; 08/28/2019; 09/04/2019
• 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