MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH VERSE X25 INSERTER/TIGHTENER; SCREWING POWERTOOL ATTACHMENT

Model Number 299704230

Device Problem Degraded (1153)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/28/2019

Event Type  malfunction  

Manufacturer Narrative

If the information is unknown, not available or does not apply, the section/field of the form is left blank.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 reports an event in (b)(6) as follows: it was reported that on (b)(6) 2019, the verse torque handle was not torquing off at required 80 in-lb.A second verse torque handle was available to finish the operation.The torque limiting handle was checked (6 clicks) and is torqueing at 10.07, 9.93, 9.98, 9.93, 9.92, 9.95.Limit range is 8.13nm to 9.94nm.The verse x25 inserter / tightener burred during the procedure.Both tightening ends of the verse x25 inserter/tightener are worn and burred.No further information was provided.This report is for one (1) verse x25 inserter/tightener.This is report 2 of 2 for (b)(4).

Manufacturer Narrative

Product complaint (b)(4).Product was not returned.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.Based on the information available, it has been determined that no corrective and 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.

• Brand Name: VERSE X25 INSERTER/TIGHTENER
• Type of Device: SCREWING POWERTOOL ATTACHMENT
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 9511329
• MDR Text Key: 177175338
• Report Number: 1526439-2019-52753
• Device Sequence Number: 1
• Product Code: HWE
• UDI-Device Identifier: 10705034467634
• UDI-Public: (01)10705034467634
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 11/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 299704230
• Device Catalogue Number: 299704230
• Device Lot Number: GM5397004
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1