MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH UNKNOWN SCREWS; SCREW,FIXATION,BONE

Device Problem Unintended Movement (3026)

Patient Problem No Code Available (3191)

Event Date 03/17/2020

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown screw/ 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.(b)(4).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) 2020, during a type c spinal injury procedure, the reduction instrument could not be loosened from the clip.The pedicle screw ripped off after the rod was connected.The left side had to be loosened completely and a thicker screw had to be put in place.The procedure was successfully completed with a one (1) hour surgical delay.There was no patient consequence.Concomitant device reported: unknown rod (part # unknown, lot # unknown, quantity 1), approximator flex-clip (part # 279712570, lot # unknown, quantity 1), approximator fc sleeve (part # 279712580, lot # unknown, quantity 1), unknown screws (part # unknown, lot # unknown, quantity 1).This report is for one (1) unknown screws.This is report 4 of 4 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: updated data-b5, h11.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

Concomitant device reported: approximator flex-clip (part# 279712570, lot# nw154765, quantity 1).Approximator flex-clip (part# 279712570, lot# nw141902, quantity 1).Approximator flex-clip (part# 279712570, lot# nw211054, quantity 1).Approximator flex-clip (part# 279712570, lot# nw233004, quantity 1).Approximator flex-clip (part# 279712570, lot# nw154764, quantity 1).Approximator flex-clip (part# 279712570, lot# nw154765, quantity 1).Approximator flex-clip (part# 279712570, lot# nw215534, quantity 1).Concomitant device reported: approximator fc sleeve (part# 279712580, lot# nw215553, quantity 1).Approximator fc sleeve (part# 279712580, lot# nw121892, quantity 1).Approximator fc sleeve (part# 279712580, lot# nw219500 , quantity 1).Approximator fc sleeve (part# 279712580, lot# nw138525, quantity 1).Approximator fc sleeve (part# 279712580, lot# nw153355, quantity 1).Approximator fc sleeve (part# 279712580, lot# nw137404, quantity 1).Approximator fc sleeve (part# 279712580, lot# nw219497, quantity 1).Concomitant device reported: approximator fc inserter (part# 279712590, lot# nw147159, quantity 1).Approximator fc inserter (part# 279712590, lot# nw153412, quantity 1).Approximator fc inserter (part# 279712590, lot# nw219408, quantity 1).Approximator fc inserter (part# 279712590, lot# nw121905, quantity 2).Approximator fc inserter (part# 279712590, lot# nw212280, quantity 1).Approximator fc inserter (part# 279712590, lot# nw138440, quantity 1).Approximator fc inserter (part# 279712590, lot# nw121905, quantity 1).

• Brand Name: UNKNOWN SCREWS
• Type of Device: SCREW,FIXATION,BONE
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 9953540
• MDR Text Key: 187558037
• Report Number: 1526439-2020-00847
• Device Sequence Number: 1
• Product Code: HWC
• 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: 03/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/29/2020
• Patient Sequence Number: 1
• Treatment: APPROXIMATOR FC INSERTER.; APPROXIMATOR FC INSERTER.; APPROXIMATOR FC INSERTER.; APPROXIMATOR FC INSERTER.; APPROXIMATOR FC INSERTER.; APPROXIMATOR FC INSERTER.; APPROXIMATOR FC INSERTER.; APPROXIMATOR FC SLEEVE.; APPROXIMATOR FC SLEEVE.; APPROXIMATOR FC SLEEVE.; APPROXIMATOR FC SLEEVE.; APPROXIMATOR FC SLEEVE.; APPROXIMATOR FC SLEEVE.; APPROXIMATOR FC SLEEVE.; APPROXIMATOR FC SLEEVE.; APPROXIMATOR FC SLEEVE.; APPROXIMATOR FLEX-CLIP.; APPROXIMATOR FLEX-CLIP.; APPROXIMATOR FLEX-CLIP.; APPROXIMATOR FLEX-CLIP.; APPROXIMATOR FLEX-CLIP.; APPROXIMATOR FLEX-CLIP.; APPROXIMATOR FLEX-CLIP.; APPROXIMATOR FLEX-CLIP.; APPROXIMATOR FLEX-CLIP.; UNKNOWN LOCKING/SET SCREWS.; UNKNOWN LOCKING/SET SCREWS.; UNKNOWN RODS.; UNKNOWN RODS.
• Patient Outcome(s): Required Intervention