MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH 5.5 EXP VERSE UNITIZED SET SCR; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Model Number 199721001

Device Problem Device-Device Incompatibility (2919)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/29/2020

Event Type  malfunction  

Manufacturer Narrative

Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.Reporter is (b)(6).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.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 that on (b)(6) 2020 the patient underwent for an unknown surgery.During the surgery the set screw fail to attach to the screwdriver and lock setscrew was failed to lock.The surgery was completed with another instrument.It was unknown if the surgery completed successfully.The patient outcome was unknown.Concomitant device reported: unknown screwdriver (part # unknown, lot # unknown, quantity # unknown).This complaint involves three (3) devices.This report is for (1) driving cap/threaded 5.5 exp verse unitized set scr.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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.D9: complainant part is not expected to be returned for manufacturer review/investigation.H3, h6: 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.

Manufacturer Narrative

Depuy synthese is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthese has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthese or its employees that the report constitutes an admission that the device, depuy synthese, 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.H3, h6: the device was received, the investigation is in progress, no conclusion could be drawn at the time of filing 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.

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.The dhr of product code 199721001, lot wm2331, was reviewed and no non-conformances were observed during the manufacturing process.The product was released on december 3, 2019.Qty.288.The dhr was electronically reviewed.Investigation flow: device interaction/functional.Visual inspection: the 5.5 verse unitized set screw (p/n: 199721001, lot #: wm2331) was returned and received at the us customer quality (cq).Upon visual inspection, it was observed that the internal threads of the verse screw were stripped.There were scratches on the device but have no impact on the device functionality.No other issues were observed with the returned device.Functional test: during functional test, the two returned x25 tighteners (p/n: 299704230, lot #'s gm5013103 and gm5194901) were failed to assemble onto the returned verse unitized set screws (p/n: 199721001) as the distal tip of the inserter and the set screw internal feature used to mate with the inserters were stripped and worn out.Can the complaint be replicated with the returned device? yes.Dimensional inspection: no dimensional inspection can be performed due to post-manufacturing damage.Furthermore, the complaint relevant dimensions cannot be checked for dimensional accuracy, because of the design of the device.Document/specification review.Based on the date of manufacture, the current and manufactured revision of drawings were reviewed.Expedium verse - single lock.Complaint confirmed? yes, the device received was stripped.Hence confirming the allegation.Investigation conclusion: the complaint condition is confirmed for the 5.5 verse unitized set screw (p/n: 199721001, lot #: wm2331).There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.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: 5.5 EXP VERSE UNITIZED SET SCR
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 10899096
• MDR Text Key: 229475765
• Report Number: 1526439-2020-02287
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10705034466156
• UDI-Public: 10705034466156
• Combination Product (y/n): N
• PMA/PMN Number: K142185
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 199721001
• Device Catalogue Number: 199721001
• Device Lot Number: WM2331
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2021
• Date Manufacturer Received: 01/22/2021
• Patient Sequence Number: 1
• Treatment: UNKNOWN SCREWDRIVERS; VERSE CORRECTION KEY; VERSE X25 INSERTER/TIGHTENER; VERSE X25 INSERTER/TIGHTENER