MAUDE Adverse Event Report: DEPUY SPINE INC MOD PEDICLE PROBE ASSY

Model Number	698202545
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
Product complaint : (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 on an unknown date, the gearshift broke in the pedicle screw.It is unknown how the issue was discovered.There was no patient harm/consequence.This complaint involves one (1) device.
Additional Manufacturer Narrative
Product complaint # = > (b)(4).Udi: (b)(4).Concomitant medical products, device evaluated by mfr: corrected.Additional: 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 mod pedicle probe assy was not returned to the customer quality unit for evaluation.Thus, an investigation will be based on the image provided.After review of the image attached to the main complaint file, it can be confirmed that approximately 1 inch of the device tip has broken off due to an unknown cause.A review of the device history record could not be performed as the lot number is unknown.Without the return of the device(s), we are unable to confirm the reported issue or identify the root cause.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: MOD PEDICLE PROBE ASSY
• Common Device Name: PROBE
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8632223
• Report Number: 1526439-2019-51686
• Device Sequence Number: 1655713
• Product Code: HXB
• UDI-Device Identifier: 10705034228440
• UDI-Public: (01)10705034228440
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/01/2019

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: 698202545
• Device Catalogue Number: 698202545
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/01/2019
• Supplement Date Received by Manufacturer: 06/20/2019
• Initial Report FDA Received Date: 05/22/2019
• Supplement Report FDA Received Date: 06/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1