MAUDE Adverse Event Report: DEPUY SPINE INC MOD SQUARE EXP 5.5 SI DRIVER; SCREWDRIVER

Model Number	698341353
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/12/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 during posterior spinal fusion surgery on (b)(6) 2020, while the surgeon was placing the screw in the l2 pedicle, the tip of the custom-made screwdriver for the power ease broke off in the screw.The tip of the screwdriver remained in the screw.The screw and driver fragment were removed from the patient.The procedure was successfully completed with no surgical delay.There were no patient consequences.This report is for a mod square exp 5.5 si driver.This is report 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.A review of the receiving inspection (ri) for mod square exp 5.5 si driver was conducted identifying that lot number gm4277301 was released in a single batch.Batch1: lot qty of (b)(4) units were released on january 20, 2015 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.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 mod square exp 5.5 si driver (p/n: 698341353, lot number: gm4277301 ) was received at us customer quality (cq).Visual inspection of the complaint device showed the tip had broken cleanly off.Device failure/defect identified? yes.Dimensional inspection: since the broken piece was not available, the dimensions of the tip shaft just proximal to the break was taken.Specified dimensions: shaft proximal to tip = 3.92 +/- 0.03mm.Measured dimensions: shaft proximal to tip = 3.89mm, conforming.Device used - caliper ca215p.Document/specification review: current and manufactured were reviewed.Current and manufactured were also reviewed.No design issues or discrepancies were identified.Complaint confirmed? yes.Investigation conclusion: this complaint is confirmed as the tip has broken off.No definitive root cause could be determined based on the provided information.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.

• Brand Name: MOD SQUARE EXP 5.5 SI DRIVER
• Common Device Name: SCREWDRIVER
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 10991723
• Report Number: 1526439-2020-02394
• Device Sequence Number: 3478028
• Product Code: HXX
• UDI-Device Identifier: 10705034473703
• UDI-Public: (01)10705034473703
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/12/2020

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: 698341353
• Device Catalogue Number: 698341353
• Device Lot Number: GM4277301
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2020
• Initial Date Received by Manufacturer: 11/12/2020
• Supplement Date Received by Manufacturer: 12/23/2020
• Initial Report FDA Received Date: 12/11/2020
• Supplement Report FDA Received Date: 01/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN SCREWS; UNKNOWN SCREWS
• Patient Age: 74 YR
• Patient Weight: 72