MAUDE Adverse Event Report: DEPUY SPINE INC XPDM THORACIC PEDICLE PRB, CRV; PROBE

Model Number 279702040

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The 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 Description

Broken 279702040.Was surgery delayed due to the reported event? no.Was procedure successfully completed? yes.Were fragments generated? yes.If yes, were they removed easily without additional intervention? yes.Patient status/ outcome / consequences: no.Patient consequence description/was there a clinical outcome experienced by the patient (infection, inflammation, etc.)? no.Was other medical intervention (e.G.X-rays, additional procedures, prescriptions, otc, revision) required: no.Is the patient part of a clinical study: unknown.This complaint involves one (1) device.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Product complaint # (b)(4).Udi: (b)(4).Report type: correction.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 not returned for evaluation.A review of the device history record was conducted.No issues were identified during the manufacturing and release of this product that could have contributed to the problem reported by the customer.Without the return of the device, we are unable to confirm the reported issue or identify the root cause.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.Should more information and/or the sample be provided at a later time, this complaint will be reopened and device evaluated.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: XPDM THORACIC PEDICLE PRB, CRV
• Type of Device: PROBE
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8896333
• MDR Text Key: 179720048
• Report Number: 1526439-2019-51975
• Device Sequence Number: 1
• Product Code: HXB
• UDI-Device Identifier: 10705034198446
• UDI-Public: (01)10705034198446
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 07/29/2019

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
• Device Operator: Health Professional
• Device Model Number: 279702040
• Device Catalogue Number: 279702040
• Device Lot Number: 1210NT
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/29/2019
• Initial Date FDA Received: 08/15/2019
• Supplement Dates Manufacturer Received: 09/24/2019; 10/15/2019
• Supplement Dates FDA Received: 09/26/2019; 10/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1