MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH LUMBAR CURVED PROBE; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number	279702020N
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The 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
It was reported that on an unknown date, during an unknown surgery, the tip of the pedicle probe broke off on the right side of left vertebrae.There was surgical delay of unknown time.The procedure was successfully completed.There were fragments generated.Patient consequences were unknown.This complaint involves one (1) device.
Additional Manufacturer Narrative
Product complaint # (b)(4).Udi: (b)(4).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.Visual examination at the macroscopic level revealed that the fracture was located at 20mm from the probe¿s tip.The second half of the probe¿s tip was not returned.The fracture analysis report reveals uniform rough morphology of the fractured surface indicating that the instrument underwent a static failure.The absence of rotational deformation and a termination site implies that the probe was broken under a cantilever force.The static overloading led to a fracture of the tip.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.A definitive root cause for the probe¿s distal tip fracturing cannot be positively determined.However, the fracture analysis report reveals uniform rough morphology of the fractured surface indicating that the instrument underwent a static failure due to a single, sudden, unexpectedly high force placed on the tip of the device.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, 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: LUMBAR CURVED PROBE
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 9217642
• Report Number: 1526439-2019-52265
• Device Sequence Number: 2733722
• Product Code: OLO
• UDI-Device Identifier: 10705034388311
• UDI-Public: (01)10705034388311
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K120867
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 279702020N
• Device Catalogue Number: 279702020N
• Device Lot Number: 0710NT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2019
• Initial Date Received by Manufacturer: 09/30/2019
• Supplement Date Received by Manufacturer: 11/19/2019
• Initial Report FDA Received Date: 10/22/2019
• Supplement Report FDA Received Date: 11/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 72 YR