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

Model Number 299704130

Device Problem Material Integrity Problem (2978)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/01/2021

Event Type  malfunction  

Manufacturer Narrative

Additional narrative: only event year is known.Complainant part is not expected to be returned for manufacturer review/investigation.A review of the receiving inspection (ri) for ball tip feeler, crv was conducted identifying that lot number pu102878 was released in a single batch.Batch1: lot qty of (b)(4) units were released on january 29, 2016 with no discrepancies.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.Investigation summary: the complaint device was not received for investigation.A photo investigation was performed based on the image provided the image was reviewed and the complaint condition is confirmed.The verse curved feeler appears to be broken at the weld between the shaft and the handle in the photo provided.A definitive assignable root cause could not be determined based on the provided information.As the device was not returned, an as-received condition could not be assessed and a dimensional inspection and document/specification review were not completed.During the investigation, no product design issues or discrepancies were observed (based on the image) that may have contributed to the complaint condition.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 Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that on an unknown date, during cleaning it was noticed that the item needed to be replaced.There was no patient involvement.This report involves one (1) expedium spine system ball tip feeler (curved) 10-100mm plus or minus 4 percent.This is report 1 of 1 for (b)(4).

• Brand Name: BALL TIP FEELER, CURVED
• Type of Device: PROBE
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): SENTIO (INNOVATIVE SURGICAL SOLUTIONS, LLC); 50461 west pontiac trail; wixom MI 48393
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6103142063
• MDR Report Key: 13443981
• MDR Text Key: 288194688
• Report Number: 1526439-2022-00179
• Device Sequence Number: 1
• Product Code: HXB
• UDI-Device Identifier: 10705034467139
• UDI-Public: (01)10705034467139
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• 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
• Device Operator: Health Professional
• Device Model Number: 299704130
• Device Catalogue Number: 299704130
• Device Lot Number: PU102878
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/11/2022
• Initial Date FDA Received: 02/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/29/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1