MAUDE Adverse Event Report: DEPUY SPINE INC BALL TIP FEELER CURVED; PROBE

Model Number	275010160
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2023
Type of Reportable Event	Malfunction
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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: b3: only event year is known.E3: reporter is a j&j employee.H3, h4, h6: a review of the receiving inspection (ri) for ball tip feeler curved, was conducted identifying that lot number ty16342 was released in one batch.Batch1: lot qty of (b)(4) units were released on 18 jan 2012 with no discrepancies.Supplier : depuy : (b)(4).As a result, the ri identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer.The product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that ball tip feeler curved had the shaft with severe marks of usage, the shaft was stripped, scratched and had nicks on its surface.Additionally, the tip of the device was broken and the broken fragment was not returned.The observed condition was consistent as an end of life indicator for the device.No other issues were identified.After a visual inspection and revision of the manufacturing date of the device, it was determined that the reusable instrument device was stripped from repeated use and servicing; therefore, further investigation for the reported complaint device is not required.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed as the observed stripped condition of ball tip feeler curved would have contributed to the complained issue.There is no indication that a design or manufacturing issue has caused the complaint condition.It was determined that the reusable instrument was worn from repeated use and servicing.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 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
It was reported that on unknown date there was an allegation found during inspection of equipment.There were no patient consequences.This report involves one (1) moss miami magnum spine system ball tip feeler (curved) 6.35 10-100mm plus or minus 4.00 percent.This is report 14 of 15 for (b)(4).

• Brand Name: BALL TIP FEELER CURVED
• Common Device Name: PROBE
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA 02767 ; 3035526892
• MDR Report Key: 17309488
• Report Number: 1526439-2023-01269
• Device Sequence Number: 7261008
• Product Code: HXB
• UDI-Device Identifier: 10705034194073
• UDI-Public: 10705034194073
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

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: 275010160
• Device Catalogue Number: 275010160
• Device Lot Number: TY16342
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/03/2023
• Initial Report FDA Received Date: 07/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/18/2012
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown