MAUDE Adverse Event Report: DEPUY SPINE INC EXPEDIUM TOP NOTCH; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Model Number 179771555

Device Problem Mechanical Jam (2983)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/31/2020

Event Type  malfunction  

Manufacturer Narrative

Additional device product codes: mnh, kwp, kwq, osh, and mni.Complainant part is expected to be returned for manufacturer review/ investigation, but has yet to be received.The investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or 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.

Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2020, during an unknown procedure that the small screw at the connector, which is used to fixate the rods, could be turned.There was no reported surgical delay.There was no adverse harm to the patient.The surgery was completed successfully with another exp connector instrument.Concomitant device reported: rods (part unknown, lot unknown, quantity unknown).This report involves one (1) expedium spine system side loading open/open top notch connector 5.5 x 5.5mm.This is report 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H3, h4, h6: a review of the receiving inspection (ri) for conn o/o sd top ntch 5.5x5.5 t was conducted identifying that lot number nw247637 was released in a single batch.Batch1: lot qty of 396 units were released on 26-jan-2020 with no discrepancies.As a result, the ri identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer.Visual inspection: the conn o/o sd top nrc 5.5 x 5.5 t (p/n: 179771555, lot #: nw247637) was returned and received at us customer quality (cq).Upon visual inspection, the set screw was partially assembled with the device and no other issues were identified with the returned components of the device.Functional test: the functional test was performed on the returned device.During functional test, the set screw was observed to be jammed and failed to assemble/disassemble from the device which caused the complaint condition.Can the complaint be replicated with the returned device? yes.Dimensional inspection: a dimensional inspection was not performed as the internal components were inaccessible without destruction of the device.Document/specification review: based on the date of manufacture, the current and manufactured revision of drawings were reviewed expedium adult: 5.5 embedded top notch connector, ti.Expedium adult: m7 short set screw, ti.Complaint confirmed? yes, the device received was jammed.Hence confirming the allegation.Investigation conclusion: the complaint condition was confirmed for the conn o/o sd top nrc 5.5 x 5.5 t (p/n: 179771555, lot #: nw247637).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: EXPEDIUM TOP NOTCH
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 10471045
• MDR Text Key: 219520847
• Report Number: 1526439-2020-01565
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10705034077819
• UDI-Public: (01)10705034077819
• Combination Product (y/n): N
• PMA/PMN Number: K160904
• 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: 08/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 179771555
• Device Catalogue Number: 179771555
• Device Lot Number: NW247637
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2020
• Date Manufacturer Received: 09/29/2020
• Patient Sequence Number: 1
• Treatment: UNKNOWN RODS