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

Model Number 279702030N

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problem Foreign Body In Patient (2687)

Event Date 08/17/2021

Event Type  Injury  

Manufacturer Narrative

Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.The investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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 (b)(4) reports an event as follows: during a case on (b)(6) 2021, it was reported that four centimeters (4 cm) of the tip of the instrument broke off inside the patient¿s hard bone and was un-retrievable.The procedure was completed with no delay.The patient reportedly went home the next day and is doing well.There is no plan to remove the broken part in the future.This report is for a thoracic straight probe.This is report 1 of 1 for (b)(4).

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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: a review of the receiving inspection (ri) for thoracic straight probe was conducted identifying that lot number gm5335701 was released in two batches.Batch1: lot qty of (b)(4) units were released on january 7, 2019 with no discrepancies.Batch2: lot qty of (b)(4) units were released on february 1, 2019 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.Investigation summary: the complaint device was not received for investigation.An investigation was performed based on the images.The images were reviewed, and the complaint condition of a broken device can be confirmed.The end of the thoracic probe is broken.There were no postoperative radiographs provided, therefore the complaint condition of an embedded device cannot be confirmed.Document review: the following documents were reviewed: manufactured and current revisions no design issues or discrepancies were identified.A definitive assignable root cause could not be determined based on the provided information.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection was not completed during the investigation no product design issues or discrepancies were observed (based on the images) that may have contributed to the complaint condition.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.

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.Investigation summary: the complaint device was not received for investigation.An investigation was performed based on the images provided.The images were reviewed, and the complaint condition of a broken device can be confirmed.The end of the thoracic probe is broken.There were no postoperative radiographs provided, therefore the complaint condition of an embedded device cannot be confirmed.Document review: no design issues or discrepancies were identified.A definitive assignable root cause could not be determined based on the provided information.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection was not completed.During the investigation no product design issues or discrepancies were observed (based on the images) that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Visual inspection: the thoracic straight pedicle (part #: 279702030n / lot #: gm5335701) was received at us cq.The probe¿s distal tip was broken and the broken piece was not returned.The embedded piece cannot be confirmed as there was no evidence (photos or x-rays) provided showing that the fragments were embedded in the patient.No other issues were identified with the returned device.Device failure/defect identified? yes.Dimensional inspection: no dimensional inspection can be performed due to post-manufacturing damage.Complaint confirmed? yes.Conclusion: the complaint was confirmed as the received device was broken.However, the embedded device allegation was not confirmed as there were no photos or x-rays provided.Although no definitive root cause can be determined it is possible the device experienced unintended forces while in use.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.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 history lot a review of the receiving inspection (ri) for thoracic straight probe was conducted identifying that lot number gm5335701 was released in two batches.Batch1: lot qty of (b)(4) units were released on 07 jan 2019 with no discrepancies.Batch2: lot qty of (b)(4) units were released on 01 feb 2019 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 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.

• Brand Name: THORACIC STRAIGHT PROBE
• Type of Device: ORTHOPAEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer (Section G): SENTIO (INNOVATIVE SURGICAL SOLUTIONS, LLC); 50461 west pontiac trail; wixom MI 48393
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6103142063
• MDR Report Key: 12468059
• MDR Text Key: 271286105
• Report Number: 1526439-2021-01991
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 10705034388328
• UDI-Public: (01)10705034388328
• Combination Product (y/n): N
• PMA/PMN Number: K140927
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 08/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 279702030N
• Device Catalogue Number: 279702030N
• Device Lot Number: GM5335701
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/10/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/07/2019
• 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
• Patient Outcome(s): Required Intervention