MAUDE Adverse Event Report: DEPUY SPINE INC REDUCER KERRISON; MISC ORTHO SURGICAL INSTR

Model Number	2020-00-140
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/29/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).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.
Event or Problem Description
It was reported that on (b)(6) 2021, the patient underwent for spinal fusion surgery.The surgeon was performing a posterior cervical fusion with depuy synthes spine symphony.During placement of the rods, the surgeon could not get the instrument to engage the screw without coming off.The instrument is squeezed and engaged; the tips may not be moving enough to capture the screw adequately.The surgery was successfully completed with 3-minutes delay.Not harm or issues with the patient.Concomitant device reported: unknown rods (part# unknown, lot# unknown, quantity unknown).This complaint involves two (2) devices.This report is for (1) reducer kerrison.This report is 1 of 2 for (b)(4).
Additional 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: d7a, h3, h6: a review of the receiving inspection (ri) for reducer kerrison was conducted identifying that lot number mi71317 was released in a single batch.Batch1: lot qty of (b)(4) units were released on august 28, 2019 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 reducer kerrison (part# 202000140, lot# mi71317) was returned and received at us customer quality (cq).Upon visual inspection, the device was showing signs of field usage.No other issues were identified with the returned device.Functional test: a functional test was performed on the returned device.The device was operating smoothly without any resistance.However, the inner tube assembly was not contracting when the handle is completely in a closed position.The device was not functioning as intended.Can the complaint be replicated with the returned device(s)? yes.Dimensional inspection: complaint relevant dimensional analysis could not be performed due to the geometry of the device.Document/specification review: the following drawing(s) (current and manufactured to) were reviewed: kerrison reducer assembly.Reducer kerrison inner tube assembly.No design issues or discrepancies were found during this investigation.Complaint confirmed? yes.Investigation conclusion: the complaint can be confirmed for the returned device.A definitive root cause could not be identified for the reported issue from the available information.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.Based upon these results, 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: REDUCER KERRISON
• Common Device Name: MISC ORTHO SURGICAL INSTR
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): BRIDGEWATER DISTRIBUTION; 50 scotland boulevard; bridgewater MA ; MA
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 13101647
• Report Number: 1526439-2021-02661
• Device Sequence Number: 3693816
• Product Code: LXH
• UDI-Device Identifier: 10705034530567
• UDI-Public: (01)10705034530567
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 2020-00-140
• Device Catalogue Number: 202000140
• Device Lot Number: MI71317
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/30/2021
• Supplement Date Received by Manufacturer: 01/21/2022
• Initial Report FDA Received Date: 12/28/2021
• Supplement Report FDA Received Date: 01/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/28/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN RODS; UNKNOWN SCREWS
• Patient Sex: Unknown