MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH 5.5 EXP VERSE SCREW 6.0 X 45; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Model Number 199721645

Device Problem Device-Device Incompatibility (2919)

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

Event Date 11/06/2020

Event Type  malfunction  

Manufacturer Narrative

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.Reporter is jnj representative.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 screw has inner thread damaged due to multiple trying to engage correction key while the correction key has the inner grey part isn¿t locked.It was unknown if the surgery completed successfully.The patient outcome unknown.This complaint involves seven (7) devices.This report is for (1) 5.5 exp verse screw 6.0 x 45.This report is 7 of 7 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.The dhr of product code: 199721645, lot : 227037, was electronically reviewed and no non-conformances were observed during the manufacturing process.The product was released on: 12.12.2018.The complaint condition was confirmed for the 5.5 exp verse screw 6.0 x 45 (p/n: 199721645, lot #: 227037).There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.The potential cause could be due to unintended forces applied to the device.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.

Manufacturer Narrative

Product complaint # (b)(4).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.D11: concomitant product added to complaint.Investigation summary background: 1.Screw damage due to correction key damage.2.Inner grey part isn't locked.(b)(6) 2020 updated event description: this complaint involves seven (7) devices.(b)(6) 2020 updated event description: the screw has inner thread damaged due to multiple trying to engage correction key while the correction key has the inner grey part isn¿t locked.H6: investigation flow: device interaction/functional.Visual inspection: the 5.5 exp verse screw 6.0 x 45 (p/n: 199721645, lot #: 227037) was returned and received at us cq.Upon visual inspection, it was observed that the head of the screw was freely moving and one reduction tab was broken and not returned.Per expedium verse spinal system technique guide (dsus/spn/0115/0747(1) 03/16).Procedure, the removal of expedium verse screw reduction tabs at the completion of the procedure using tab remover.The remaining features of the device, including the threads, displayed no signs of damage or defect.Functional test: a functional testing and replication of the event conditions could not be performed at cq because of a single broken tab.Can the complaint be replicated with the returned device? unable to perform.Dimensional inspection: the outer diameter of the screw head was measured to be within the specification.Document/specification review: based on the date of manufacture, the current and manufactured revision of drawings were reviewed expedium verse - 4.35mm / 8mm poly screw assembly: dwg-887046545, rev.B/a dwg-887042533, rev: a.Expedium verse spinal system technique guide (dsus/spn/0115/0747(1) 03/16).No design issues or discrepancies were identified.Complaint was confirmed.Investigation conclusion: the complaint condition was confirmed for the 5.5 exp verse screw 6.0 x 45 (p/n: 199721645, lot #: 227037) as the single reduction tab was broken which could have caused the complaint condition.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.The potential cause could be due to unintended forces applied to the device.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.Comments: 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 SCREW 6.0 X 45
• 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: 10945415
• MDR Text Key: 219525838
• Report Number: 1526439-2020-02356
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10705034442273
• UDI-Public: 10705034442273
• 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
• Report Date: 11/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 199721645
• Device Catalogue Number: 199721645
• Device Lot Number: 227037
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2021
• Date Manufacturer Received: 02/02/2021
• Patient Sequence Number: 1
• Treatment: 5.5 EXP VERSE SCREW 6.0 X 40.; 5.5 EXP VERSE SCREW 6.0 X 40.; 5.5 EXP VERSE SCREW 6.0 X 45.; 5.5 EXP VERSE SCREW 6.0 X 45.; 5.5 EXP VERSE SCREW 6.0 X 45.; VERSE CORRECTION KEY.; VERSE CORRECTION KEY.; VERSE CORRECTION KEY.; VERSE CORRECTION KEY.; VERSE CORRECTION KEY.; VERSE CORRECTION KEY.; VERSE CORRECTION KEY.; VERSE CORRECTION KEY.; 5.5 EXP VERSE SCREW 6.0 X 40; 5.5 EXP VERSE SCREW 6.0 X 45; VERSE CORRECTION KEY; VERSE CORRECTION KEY; VERSE CORRECTION KEY; VERSE CORRECTION KEY