MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH UNKNOWN GUIDE/COMPRESSION/K-WIRES; NAIL, FIXATION, BONE

Device Problem No Apparent Adverse Event (3189)

Patient Problems Tissue Damage (2104); Injury (2348)

Event Date 01/16/2019

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown guide/compression/k-wires/unknown lot.Part and lot numbers are unknown; udi number is unknown.Without a lot number the device history records review could not be completed.Product was not returned.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 screw slipped off pedicle and was inserted into l4/5 disc space.Brainlab jam shiidi and 1.45mm guidewire were also used.The v2 ratcheting t handle was unable to be removed after the procedure.Surgical delay of thirty minutes was reported.This report is for one (1) unknown guide/compression/k-wires this is report 2 of 2 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.Product was not returned.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.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

This is report 2 of 4 for (b)(4).

• Brand Name: UNKNOWN GUIDE/COMPRESSION/K-WIRES
• Type of Device: NAIL, FIXATION, BONE
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 9445533
• MDR Text Key: 185518172
• Report Number: 1526439-2019-52654
• Device Sequence Number: 1
• Product Code: JDS
• Combination Product (y/n): N
• 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: 11/16/2019

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?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/16/2019
• Initial Date FDA Received: 12/10/2019
• Supplement Dates Manufacturer Received: 02/12/2020
• Supplement Dates FDA Received: 02/13/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention