MAUDE Adverse Event Report: DEPUY SPINE INC VIPER PRIME ROD HOLDER STEM; MISC ORTHO SURGICAL INSTR

Model Number	286750061
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/31/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.Reporter is company representative.Without a lot number, the device history records review could not be completed as no product was received.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 or Problem Description
Device report from synthes reports an event in (b)(6) as follows: it was reported on an unknown date that the patient underwent for an unknown surgery on (b)(6) 2020.During the surgery it was discovered that the rod holder stem uncoupled and making difficult its extraction.It was unknown if the surgery was completed successfully with or without delay.There were no consequences of patient reported.Concomitant device reported: unknown rod (part# unknown, lot# unknown, quantity unknown.This complaint involves one (1) device.This report is 1 of 1 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.H3, h4, h6: a review of the receiving inspection (ri) for viper prime rod holder stem was conducted identifying that lot number mi72175 was released in a single batch on january 11, 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.H3, h6: a product investigation was completed: upon visual inspection, scratches were observed on the device but have no impact to the device functionality.No other issues were observed with the returned device.A functional test was not performed as the mating devices were not returned.The internal diameter of the slot on the holder stem was measured to be within the specification.Based on the date of manufacture, the current and manufactured revision of drawings were reviewed.The complaint condition was not confirmed.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: VIPER PRIME ROD HOLDER STEM
• Common Device Name: MISC ORTHO SURGICAL INSTR
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 10144036
• Report Number: 1526439-2020-01160
• Device Sequence Number: 14051548
• Product Code: LXH
• UDI-Device Identifier: 10705034507675
• UDI-Public: 10705034507675
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/31/2020

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: 286750061
• Device Catalogue Number: 286750061
• Device Lot Number: MI72175
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2021
• Initial Date Received by Manufacturer: 05/31/2020
• Supplement Date Received by Manufacturer: 03/17/2021
• Initial Report FDA Received Date: 06/11/2020
• Supplement Report FDA Received Date: 03/23/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN RODS; UNKNOWN RODS