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

Device Problem Unintended Movement (3026)

Patient Problem No Code Available (3191)

Event Date 09/02/2020

Event Type  Injury  

Manufacturer Narrative

510k: this report is for an unknown locking/set screws/unknown lot.Part and lot numbers are unknown; udi number is unknown.Reporter is jnj representative.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.(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 (b)(6) reports an event as follows: it was reported on (b)(6) 2020, that the patient underwent for an unknown surgery.During the surgery, the both inserters weren't able to tighten as the tip was worn.When they tried to do the final tightening the x25 inserter ran inside the innies.The innies weren't completely tight.The surgery was delayed 20 minutes.The procedure was not completed successfully.The patient outcome was unknown.This complaint involves six (6) devices.This report is for (1) unknown locking/set screws.This is report 1 of 3 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.H6: patient code 3191 used to capture additional medical/surgical intervention required, modified surgical procedure and surgery prolonged.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) 2020, during an anterior/posterior (a & p) lumbar fusion procedure, the tip of the two (2) x25 inserter/tighteners were worn and did not allow to make the final tightening properly.The tighteners could be use fine for first tightening, but when surgeon tried to do the final tightening the x25 inserters ran inside the innies.The innies weren¿t completely tight, as the surgical technique advise.There is no direct impact to the patient, but the surgery was delayed for twenty (20) minutes.It was noted there were four (4) total innies used during the surgery.Concomitant device reported: locking/set screws (part # unknown, lot # unknown, quantity unknown).This is report 4 of 6 for (b)(4).

• Brand Name: UNKNOWN LOCKING/SET 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: 10608207
• MDR Text Key: 209225937
• Report Number: 1526439-2020-01831
• 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: 09/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2020
• 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: 09/29/2020
• Patient Sequence Number: 1
• Treatment: UNKNOWN LOCKING/SET SCREWS
• Patient Outcome(s): Required Intervention