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

Model Number	283904413
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/14/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.(b)(4).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
Device report from synthes reports an event in (b)(6) as follows: it was reported on an unknown date, that the patient underwent for a surgery.During the kyphoplasty, the tip of the side hole needle was broke-off and remained in the patient.It was unknown if there was a surgical delay.There were fragments generated but no plans in removing the remaining broken parts in the patient.The patient status is good.The procedure outcome is unknown.This complaint involves one (1) device.This report involves one (1) unk - drill bits: trauma.This is report 1 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.H10 additional narrative: h3, h6: investigation summary: customer quality investigation: the complaint device was not received for investigation.The following investigation is based on the image(s) provided.The image(s) was reviewed, and the complaint condition could be confirmed as the device was broken in 2+ pieces along the shaft.No fragments were visible in the image provided.Since the device was not returned, a dimensional inspection and a functional test were not able to be performed.A definitive assignable root cause could not be determined based on the provided information.During the investigation no product design issues or discrepancies were observed (based on the images) that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.,background: investigation flow: damage visual inspection: the conf.Intro needle, side, 13g 4" (p/n: 283904413, lot #: unk) was returned and received at us cq.Upon visual inspection, it was observed that the distal tip of the device was observed to be broken.The stylet assembly was able to lock/unlock without any issues.No other issues were observed with the returned device.The device failure/defect is identified.Dimensional inspection: no dimensional inspection can be performed due to post-manufacturing damage.Document/specification review since the exact manufactured date of the device was not identified, the current revision of drawings were reviewed.The complaint is confirmed.The device received was broken.Hence confirming the allegation.Investigation conclusion the complaint condition is confirmed for the conf.Intro needle, side, 13g 4" (p/n: 283904413, lot #: unk).There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.The potential cause could be due to unintended forces applied to the device.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 history lot a manufacturing record evaluation could not be performed as the lot number could not be determined from the image provided.,dhr was not performed as the lot number is unknown.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: CONF INTRO NDLE, SIDE, 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: 11240114
• Report Number: 1526439-2021-00204
• Device Sequence Number: 3806021
• Product Code: GAA
• UDI-Device Identifier: 10705034209524
• UDI-Public: 10705034209524
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/05/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: 283904413
• Device Catalogue Number: 283904413
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2021
• Initial Date Received by Manufacturer: 01/05/2021
• Supplement Date Received by Manufacturer: 02/16/2021
• Initial Report FDA Received Date: 01/27/2021
• Supplement Report FDA Received Date: 02/22/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 77 YR