MAUDE Adverse Event Report: DEPUY SPINE INC VSP SOUNDING PROBE

Model Number	202549
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2019
Type of Reportable Event	Malfunction
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 the surgeon reported ball tip broke off end of probe during normal use.Another probe was opened, tip was retrieved and no unaccounted fragments.Customer reference/po/service: (b)(4).Was surgery delayed due to the reported event? no.Action taken when event occurred? opened a second package.Was procedure successfully completed? yes.Were fragments generated? no.If yes, were they removed easily without additional intervention? yes.Patient status/ outcome / consequences? no.Was other medical intervention (e.G.X-rays, additional procedures, prescriptions, otc, revision) required: unknown.Is the patient part of a clinical study? unknown.
Additional Manufacturer Narrative
Product complaint #: (b)(4).Udi: (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.The probe is broken at its distal tip.The ball at the end of the probe is missing.The probe was measured, and approximately 0.5cm of the tip excluding the ball was also missing.The distal end of the tip that broke off was not returned.Fracture analysis was subsequently performed on the broken device.Optical imaging of the fractured surface of the device reveals a rough surface.This indicates a single, sharp, heavy load being placed on the tip.No material defects of other abnormalities were observed in this analysis.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.All complaint trends will be evaluated as a part of the depuy spine monthly complaint review meeting.The root cause of the tip of the device breaking cannot be determined from the sample and the information provided.The results of fracture analysis have determined that a probable root cause is static overload failure due to a single, sudden, unexpectedly high force placed on the tip.It has also been noted that wear may be a factor, as the device is upwards of 12 years old.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 and no systemic trends were found, 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: VSP SOUNDING PROBE
• Common Device Name: PROBE
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8327869
• Report Number: 1526439-2019-51336
• Device Sequence Number: 1789462
• Product Code: HXB
• UDI-Device Identifier: 10705034000398
• UDI-Public: (01)10705034000398
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/18/2019

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
• Operator of Device: Health Professional
• Device Model Number: 202549
• Device Catalogue Number: 202549
• Device Lot Number: 0307V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2019
• Initial Date Received by Manufacturer: 01/18/2019
• Supplement Date Received by Manufacturer: 04/05/2019
• Initial Report FDA Received Date: 02/11/2019
• Supplement Report FDA Received Date: 04/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1