MAUDE Adverse Event Report: DEPUY SPINE INC 5MM TAP, DUAL LEAD CANN; ORTHOPAEDIC STEREOTAXIC INSTRU

Model Number 286715500N

Device Problem Break (1069)

Patient Problems No Consequences Or Impact To Patient (2199); No Code Available (3191)

Event Date 05/19/2020

Event Type  malfunction  

Manufacturer Narrative

Additional narrative: 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 Description

It was reported that on (b)(6) 2020, during a lumbar fusion l4/5 surgery, the two cannulated viper taps broke off into the pedicles right above the threads.One in each pedicle.A synthes screw removal set was used to extract the pieces.Fragments were generated and removed.There was a surgical delay of twenty (20) minutes.There were no patient consequences.The procedure was successfully completed.This complaint involves two (2) devices.This is report 1 of 2 for (b)(4).

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.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.

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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H6: 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 distal tip of the device was broken.Since the device was not returned, dimensional, material and drawing reviews are not applicable.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.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: 5MM TAP, DUAL LEAD CANN
• Type of Device: ORTHOPAEDIC STEREOTAXIC INSTRU
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 10106396
• MDR Text Key: 194459419
• Report Number: 1526439-2020-01094
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 10705034388489
• UDI-Public: (01)10705034388489
• Combination Product (y/n): N
• PMA/PMN Number: K140927
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 05/19/2020

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
• Device Operator: Health Professional
• Device Model Number: 286715500N
• Device Catalogue Number: 286715500N
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/19/2020
• Initial Date FDA Received: 06/01/2020
• Supplement Dates Manufacturer Received: 06/29/2020; 06/29/2020
• Supplement Dates FDA Received: 06/29/2020; 06/29/2020
• Patient Sequence Number: 1
• Patient Age: 51 YR