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

Catalog Number	299704125
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2024
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.Additional narrative: h6: a review of the receiving inspection (ri) for ball tip feeler, straight, was conducted identifying that lot pu160772 was released in five batches.¿ batch1: released on july 1, 2020 with no discrepancies.¿ batch2: released on january 27, 2021 with no discrepancies.¿ batch3: released on june 2, 2021 with no discrepancies.¿ batch2: released on july 14, 2021 with no discrepancies.¿ batch2: released on july 14, 2021 with no discrepancies.Supplier: depuy: (b)(4).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.Visual inspection of the returned device found that the weld between the shaft and the handle was broken, therefore, the shaft separated, confirming the reported condition.Shaft was not returned for analysis.The observed condition of the device was consistent with a component failure that was caused by exposure to unintended forces like improper handling, excessive force during use, or accidental impact.A dimensional inspection was unable to be performed due to the post-manufacturing damage.The overall complaint was confirmed as the observed condition of the ball tip feeler, straight would contribute to the complained device issue.Based on the investigation findings, the potential cause is traced to a component failure , and it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.The drawings reflecting the current and manufactured revisions were reviewed.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 an unknown date in 2024, (b)(4) staff at the hospital found a pedicle feeler where the distal end had separated from the proximal shaft.There was no patient consequence.This report is for a ball tip feeler, straight.

• Brand Name: BALL TIP FEELER, STRAIGHT
• 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: 20169290
• Report Number: 1526439-2024-02301
• Device Sequence Number: 7002900
• Product Code: HXB
• UDI-Device Identifier: 10705034467146
• UDI-Public: (01)10705034467146(10)PU160772
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Foreign,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 Catalogue Number: 299704125
• Device Lot Number: PU160772
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/14/2024
• Initial Report FDA Received Date: 09/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2020
• 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