MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH BALL TIP FEELER, STRAIGHT; PROBE

Model Number	299704125
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is available for evaluation.Investigation will be conducted.Follow up will be filed with the investigation results.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
On (b)(6) 2018, the posterior fixation surgery was performed for vertebral osteomyelitis.After the surgery, it was found during washing that the tip part of ball tip feeler ((b)(4), lot: pu118684) had been separated from its handle part.This event did not affect the surgery at all because the reported device was not used.The surgery was successfully completed, and there was no adverse consequence to the patient.It is unknown about when and how this event occurred because the reported device was not used.
Additional Manufacturer Narrative
Product complaint # (b)(4).Visual examination at the macroscopic level reveals that the failure occurred at the weld connection between the tip and the body of the device.Device was then sent for fracture analysis.The fracture analysis report reveals that the failure was due to a static overload.No material defects or other abnormalities were observed in this analysis.A review of the device history record was conducted.No issues were identified during the manufacturing and release of this product that could have contributed to the problem reported by the customer.All complaint trends will be evaluated as a part of the depuy spine monthly complaint review meeting.A definitive root cause for the ball tip feeler breaking at the weld connection between the tip and the body cannot be positively determined.However, the fracture analysis report reveals that the failure was due to a static overload.As there has been no issue identified in the manufacturing or release of the device that could have contributed to the problem reported by the customer and no systemic trends were found, this complaint file will be closed with no further action required.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: BALL TIP FEELER, STRAIGHT
• Common Device Name: PROBE
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 7437496
• Report Number: 1526439-2018-50371
• Device Sequence Number: 18915735
• Product Code: HXB
• UDI-Device Identifier: 10705034467146
• UDI-Public: (01)10705034467146
• Combination Product (Y/N): N
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/23/2018

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: 299704125
• Device Catalogue Number: 299704125
• Device Lot Number: PU118684
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2018
• Initial Date Received by Manufacturer: 03/23/2018
• Supplement Date Received by Manufacturer: 05/07/2018
• Initial Report FDA Received Date: 04/17/2018
• Supplement Report FDA Received Date: 05/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1