MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH 4.0 PLY SCRW 4.0X16; ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION

Model Number 1020-40-116

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Date 12/15/2020

Event Type  Injury  

Manufacturer Narrative

Additional product code: kwp.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

It was reported that on (b)(6) 2020, during c2-t2 posterior spinal fusion surgery the surgeon was implanting c2 screw and it broke at the shank beneath tulip head.Surgeon drilled and tapped with 3.0 tap; screw broke as screw head getting flush with bone.Patient¿s bone quality was described as medium.There was a surgical delay of twenty (20) minutes.There were no fragments generated.There were no patient consequences.The procedure was successfully completed by removing the screw shank from pedicle and had to burr down bone to remove with vice grips.There were no patient consequences.Concomitant device reported: unknown drill (part# unknown, lot# unknown, quantity unknown); unknown probe (part# unknown, lot# unknown, quantity unknown).This complaint involves one (1) device.This report is for (1) reamer head f/ria 2 ø10.This report is 1 of 1 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.Investigation summary: photo investigation: the device was not returned.A photo-investigation was performed on the images.The broken condition was observed near/at the distal thread start.All fragments were visible.No other issues were observed besides scratching consistent with implant/explant.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 not confirmed during investigation.No device malfunction, damage, or defect was noted during investigation.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.Investigation flow: damage.Visual inspection: visual inspection performed at customer quality (cq) showed a screw broke just below tulip head portion.A device failure was identified.Dimensional inspection: drawing: oø: measured dimensions: ø (near broken spot): conforming.Device used: ca122p.Document/specification review: the following drawings were reviewed: polyscrew, 4.0 rod, 4.0x08-50, std shank, 4.0x08-18.Based on the review of the above drawings, no design issues contributing to relevant complaint condition were identified.Conclusion: no definitive root cause was able to be determined as the circumstances surrounding the complaint are unknown.During the investigation no unidentified product design/manufacturing issues or discrepancies were observed that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Device history lot: the dhr of product code 102040116, lot 273178, was reviewed and no non-conformances were observed during the manufacturing process.The product was released on february 25, 2020.The dhr was electronically reviewed.Device history review: no non-conformances were observed during the manufacturing process.A mre could not be performed, as the lot number could not be determined from the implant.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: 4.0 PLY SCRW 4.0X16
• Type of Device: ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 11148894
• MDR Text Key: 226094690
• Report Number: 1526439-2021-00130
• Device Sequence Number: 1
• Product Code: NKG
• UDI-Device Identifier: 10705034512259
• UDI-Public: 10705034512259
• Combination Product (y/n): N
• PMA/PMN Number: K181949
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 12/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1020-40-116
• Device Catalogue Number: 102040116
• Device Lot Number: 273178
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2021
• Date Manufacturer Received: 01/12/2021
• Patient Sequence Number: 1
• Treatment: UNKNOWN DRILL; UNKNOWN PROBES; UNKNOWN DRILL; UNKNOWN PROBES
• Patient Outcome(s): Required Intervention