MAUDE Adverse Event Report: DEPUY SPINE INC MOSS MIAMI MAGNUM SPINE SYSTEM BALL TIP FEELER (CURVED) 6.35 10-100MM +/- 4.00%; PROBE

Model Number	275010160
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/11/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Device report from canada reports an event as follows: it was reported that on (b)(6) 2022, the operating room staff identified the pedicle sound was missing the distal tip pre-operatively.The instrument was not used during the operation and removed from the operating room.The pedicle sound distal end had been severed and was not on the instrument, it confirmed not present in the tray during incident.The reprocessing area was searched and still was not found.The sound was removed and sent to the complaints department.There was no reported patient interaction.This report is for a moss miami magnum spine system ball tip feeler (curved) 6.35 10-100mm +/- 4.00% this is report 1 of 1 for (b)(4).
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.A review of the receiving inspection (ri) for ball tip feeler curved was conducted identifying that lot number ty19135 was released in one batch.Batch 1: lot qty of 54 units were released on (b)(6) 2016 with no discrepancies supplier: troy innovative 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 was was observed with the ball tip feeler shaft broken.The broken fragment was not received in the evidence provided.A dimensional inspection for the ball tip feeler curved was unable to be performed due to post manufacturing damage.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to unintended forces.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 condition of the ball tip feeler curved would contribute to the complained device issue.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.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.

• Brand Name: MOSS MIAMI MAGNUM SPINE SYSTEM BALL TIP FEELER (CURVED) 6.35 10-100MM +/- 4.00%
• Common Device Name: PROBE
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kate karberg ; chemin-blanc 38; le locle ; SZ ; 3035526892
• MDR Report Key: 16073138
• Report Number: 1526439-2022-02225
• Device Sequence Number: 6294429
• Product Code: HXB
• UDI-Device Identifier: 10705034194073
• UDI-Public: (01)10705034194073
• 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 Model Number: 275010160
• Device Catalogue Number: 275010160
• Device Lot Number: TY19135
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/12/2022
• Initial Report FDA Received Date: 12/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/16/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown