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	03/24/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Complainant part returned.The device was received, the investigation could not be completed, and no conclusion could be drawn, a review of the device history records has been requested and is currently pending completion.As product is entering the complaint system.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, during a revision surgery the tip of powerease 5.5 custom screwdriver broke off as the surgeon was going to put the screw into very hard bone, requiring excessive torque which, in turn, broke the tip of the screwdriver off in the screw.The fragment was easily removed from the screw but was subsequently suctioned into a closed suction system.The broken tip was unable to be recovered, but the driver was.There was no surgical delay.Patient status is unknown.The procedure was successfully completed.Concomitant device reported: unknown screw (part# unknown, lot# unknown, quantity unknown).This complaint involves one (1) device.This report is 1 of 1 for (b)(4).
Event or Problem Description
It was reported that the revision procedure was performed to extend up a level due to degenerative changes.
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: b5 h3, h6: a product investigation was conducted.Visual inspection: the mod square exp 5.5 si driver (p/n: (b)(4) , lot #: gm4277301) was returned and received at us cq.Upon visual inspection, it was observed that the distal tip was broken and the broken fragment was not returned.The pictures provided was reviewed and it does not impact the investigation.No other issues were observed with the returned device.Dimensional inspection: the distal tip was measured and is within the specification per relevant drawing.Document/specification review: based on the date of manufacture, the current and manufactured revision of drawings were reviewed yes, the device received was broken.Hence confirming the allegation.Investigation conclusion: the complaint condition was confirmed for the mod square exp 5.5 si driver (p/n: (b)(4) , lot #: gm4277301).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.H3, h6: a device history record (dhr) review was conducted: 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.(b)(4).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.D7a.

• 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: 11694212
• Report Number: 1526439-2021-00749
• Device Sequence Number: 11631360
• Product Code: HXX
• UDI-Device Identifier: 10705034473703
• UDI-Public: (01)10705034473703
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• 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): 03/24/2021

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: 04/12/2021
• Initial Date Received by Manufacturer: 03/24/2021
• Supplement Date Received by Manufacturer: 04/23/2021
• Initial Report FDA Received Date: 04/20/2021
• Supplement Report FDA Received Date: 05/18/2021
• 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: MOD SQUARE EXP 5.5 SI DRIVER; UNKNOWN SCREWS; UNKNOWN SCREWS; MOD SQUARE EXP 5.5 SI DRIVER; UNKNOWN SCREWS
• Patient Age: 49 YR