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 Crack (1135)

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

Event Date 02/26/2021

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Additional product code : kwp; kwq; mnh; mni; osh.Complainant part is expected to be returned for manufacturer review/ investigation but has yet to be received.Investigation summary: photo investigation: the device was not returned.A photo-investigation was performed on the images.The set screw's threads were peeled off.No other issues were noted.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.Conclusion: the complaint was confirmed.During the investigation, no product design issues or discrepancies were observed.No manufacturing issues were noted during investigation.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Therefore, it has been determined that no corrective and/or preventive action is proposed.Device history lot: the dhr of product code 199721001, lot wm2112, was reviewed and no non-conformance were observed during the manufacturing process.The product was released on november 19, 2019.Qty.(b)(4).The dhr was electronically reviewed.Device history review: no manufacturing issues were observed during dhr review.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) 2021, the patient underwent for a surgery.During the surgery, of posterior lumbar internal fixation, when final tightened the inner set screw, the thread was peeled.The surgeon also removed verse screw which was connect with the inner set screw.It was unknown if the surgery completed successfully.There were no patient consequences are reported.Concomitant device reported: unknown tightener (part # unknown, lot # unknown, quantity unknown).This complaint involves two (2) devices.This report is for (1) 5.5 exp verse unitized set scr.This report is 2 of 2 (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: h3, h6: visual inspection: the 5.5 exp verse unitized set scr was received at us customer quality (cq).Visual inspection of the complaint device showed half of the external threads had broken off.Per received picture, the internal threads that connect to the screwdriver tip appear to be deformed, possibly from over-torqueing.Dimensional inspection: a dimensional inspection was not performed due to post-manufacturing damage.Document/specification review: current and manufactured revisions were reviewed.Expedium verse system guide was also reviewed.No design issues or discrepancies were identified.Investigation conclusion: this complaint is confirmed as half of the external threads had broken off.No definitive root cause could be determined based on the provided information.However, the condition of the outer threads and inner threads is consistent with over-torqueing of the set screw.Therefore, it is possible that the set screw was torqued beyond the required amount of 80in-lb from the expedium verse system guide.The system guide contains a warning that care must be taken to ensure that the torque wrench handle is set to 80 in-lb (9n-m).There was no indication that a design or manufacturing issue contributed to the complaint.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.D7: it is unknown if this was a single-use device that was reprocessed and reused.

• 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: 11599649
• MDR Text Key: 244625019
• Report Number: 1526439-2021-00603
• 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
• Report Date: 03/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2021
• 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: WM2112
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2021
• Date Manufacturer Received: 04/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Treatment: 5.5 EXP VERSE SCREW 6.0 X 45; UNKNOWN TIGHTENER