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

Model Number 275010140

Device Problem Use of Device Problem (1670)

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

Event Date 09/28/2020

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).The device has been received.Investigation summary: background: the scrubbed nurse noticed that the ball tip probe was missing its distal end tip 'ball'.She simply removed it from her table and they proceeded with the case with the other ball tip probe found in the system.No delay was obtained, no patient consequences resulted from this.I have nothing further to add.The instrument will be shipped via puro at the markham office.This complaint involves one (1) device investigation flow: damage visual inspection: the ball tip feeler, straight (p/n 275010140 lot 0705v) was received at customer quality, and it was observed that the ball tip was broken, and not returned.No other issues were identified with the returned components of the device.The complaint of is confirmed.Device failure/ defect was identified.Dimensional inspection: the drawing(s) was reviewed: expedium ball tip feeler shaft (straight) dwg-2750-10-141 rev b conclusion: the measuring result does show conformity.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.Document/ specification review: the following drawing was reviewed: -expedium ball tip feeler shaft (straight) dwg-2750-10-141 rev c/b.-ball tip feeler assembly (straight) dwg-2750-10-140 rev d/h.Complaint was confirmed investigation conclusion: this complaint is confirmed however no product design issues or manufacturing discrepancies that would contribute to the reported complaint condition were identified during this investigation.No new, unique or different patient harms were identified because of this evaluation.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Device history lot: a review of the receiving inspection (ri) for ball tip feeler straight was conducted identifying that lot number 0705v was released in six batches.Batch1: lot qty of 33 units were released on 10 may 2006 with no discrepancies.Batch2 : lot qty of 84 units were released on 24 mar 2006 with no discrepancies.Batch3: lot qty of 150 units were released on 28 jul 2006 with no discrepancies.Batch4: lot qty of 165 units were released on 21 sep 2005 with no discrepancies.Batch5: lot qty of 56 units were released on 117 feb 2006 with no discrepancies.Batch6: lot qty of 104 units were released on 117 feb 2006 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.Device history batch null, device history review the ri identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer.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 the scrubbed nurse noticed that the ball tip probe was missing its distal end tip 'ball'.She removed it from her table and they proceeded with the case with the other ball tip probe found in the system.No delay was obtained, no patient consequences resulted from this.The instrument will be shipped via puro at the markham office.This complaint involves one (1) device this report is for one (1) ball tip feeler straight this is report 1 of 1 for complaint (b)(4).

• Brand Name: BALL TIP FEELER STRAIGHT
• Type of Device: ORTHOPAEDIC FEELER
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA ; 6103142063
• MDR Report Key: 10920958
• MDR Text Key: 234372057
• Report Number: 1526439-2020-02304
• Device Sequence Number: 1
• Product Code: HXB
• UDI-Device Identifier: 10705034194066
• UDI-Public: (01)10705034194066
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 275010140
• Device Catalogue Number: 275010140
• Device Lot Number: 0705V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/05/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/21/2005
• 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