MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH THORACIC CURVED PROBE; ORTHOPAEDIC STEREOTAXIC INSTRUMENT

Model Number	279702040N
Medical Device Problem Codes	Break (1069); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/08/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.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 or Problem Description
Device report from synthes reports an event in (b)(6) as follows: it was reported on an unknown date that the patient was underwent for an expedium fusion surgery.The surgeon was breaking the thoracic curved pedicle probe inside the patient.Also, the torque drive shaft stripped at the distal end tip.The end tip of the probe was removed.The procedure was completed without any delay.There was no patient consequence.Concomitant device reported: unknown screws (part#: unknown, lot#: unknown, quantity: unknown).This is report 2 of 2 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.The xpdm thoracic pedicle prb, crv (p/n 279702040 s/n (b)(6) was received at customer quality, and upon visual inspection, it was observed that the distal tip of the device was broken.The broken off piece was not returned for evaluation.The complaint condition is confirmed.A definitive assignable root cause for the post manufacturing damage could not be determined based on the provided information.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 device history record (dhr) could not be performed as no manufacturing records could be found for this part # 279702040 / lot # 0708v combination.If further information becomes available, this dhr can be revisited.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.
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.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: THORACIC CURVED PROBE
• Common Device Name: ORTHOPAEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 9616548
• Report Number: 1526439-2020-00424
• Device Sequence Number: 503832
• Product Code: OLO
• UDI-Device Identifier: 10705034388335
• UDI-Public: (01)10705034388335
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K120867
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/09/2020

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: 279702040N
• Device Catalogue Number: 279702040
• Device Lot Number: 0708V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2020
• Initial Date Received by Manufacturer: 01/09/2020
• Supplement Date Received by Manufacturer: 02/18/2020; 02/21/2020
• Initial Report FDA Received Date: 01/22/2020
• Supplement Report FDA Received Date: 02/19/2020; 02/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN SCREWS