MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH T-HANDLE, RATCHETING; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number 299704135

Device Problem Disconnection (1171)

Patient Problem No Code Available (3191)

Event Date 08/07/2019

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Pc: dural tear.(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 Description

It was reported that on (b)(6) 2019, during instrument pass into the surgical site for spinal fusion (l4-l5).The t-handle malfunctioned, disassembled and released; the screwdriver assembly and screw into the surgical wound, resulting in a dural tear and trauma to the thecal sac at l4-l5.Thus the malfunctioning handle was removed from the sterile field and replaced with a working handle.There was a surgical delay of 190 (one hundred ninety) minutes.The procedure was completed the patient outcome was unknown.This complaint involves one (1) device.

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.Product development engineer at gauthier biomedical has performed the investigation for the failure of the device.It was noted that the (handle/button housing) had detached from the (main gear).The handle/button housing is secured to the main gear using two pins.Once the handle was disassembled, it was found that these two pins were not protruding far enough out to connect through the mating holes.The two features that affect how far the pin protrudes is the pin length and the mating hole depth.The pin length was inspected on both pins and measured in specification.The depth of the pin holes were out of tolerance and too deep.This caused the pins to get pressed too far into the shaft resulting in not enough of the pin protruding through the mating hole in the body.Due to this, a proper attachment could not be secured.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.The received condition of the device is concordant with the complaint description and the complaint condition is confirmed.Based on the provided information we are not able to determine the exact cause of this complaint but the failure analysis conducted by the supplier identified the depth of the pin holes were out of tolerance and too deep.This caused the pins to get pressed too far into the shaft resulting in not enough of the pin protruding through the mating hole in the body.Due to this, a proper attachment could not be secured.This issue is related to the manufacturing and therefore a non-conformance has been opened.Further investigation will conducted on the non-conformance and therefore, this complaint will be closed with no further action required.If more information becomes available at a later date, the complaint will be reopened and the issue will be further addressed.

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.H11: corrected data: g4: awareness date reported on follow up 2 report as october 27, 2019 but should have been october 27, 2020.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.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

It was reported that on (b)(6) 2019, the patient underwent an l4-l5 laminectomy, instrumented fusion with reduction of l4-5 anterolisthesis, transforaminal interbody placement, use of allograft and aurograft fusion, intra-operative navigation and airo ct and insertion of lumbar drain indicated by neurogenic claudication, intractable back and leg pain that has failed conservative care.Intra-operatively, during the placement of the l5 screw, the driver with the screw detached from the handle and fell into the thecal sac resulting in an approximately 1cm dural tear extending just rostral to the shoulder of the l5 traversing nerve root down to just caudal to the axilla of the traversing nerve root.The tear was just lateral and the screw was immediately removed and the csf leak was tamponaded immediately with cottonoids with complete control of the csf leak.It was concluded that the driver with the screw had detached from the ratcheting t-handle.The final l5 screw was placed with a new handle-driver system.Because of the malfunctioning equipment and subsequent injury to the patient's spinal column resulting in a tear, the patient was on the operating table for about 12 hours under continuous anesthesia.There was a surgical delay of 190 minutes.The patient was transferred to the recovery room in satisfactory condition and neuromonitoring was stable throughout the case.

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.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: T-HANDLE, RATCHETING
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 8937550
• MDR Text Key: 156413014
• Report Number: 1526439-2019-52046
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 10705034467306
• UDI-Public: (01)10705034467306
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 08/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 299704135
• Device Catalogue Number: 299704135
• Device Lot Number: GB115455
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2019
• Date Manufacturer Received: 11/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN SCREWDRIVERS; UNKNOWN SCREWS
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR
• Patient Weight: 120