MAUDE Adverse Event Report: DEPUY SPINE INC VIPER PRIME T-HANDLE; ORTHOPAEDIC STEREOTAXIC INSTRUMENT

Model Number	286750035
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reporter is a synthes employee.The device was received, the investigation could not be completed, and no conclusion could be drawn, 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
Device report from (b)(6) reports an event as follows: it was reported that on (b)(6) 2021 that the nurse wanted to remove the prime stylet depth adjustor from the screwdriver to adapt the stylet depth.While removing it, it got stuck in the t-handle.It was not possible to remove either of the articles from the screwdriver.The depth adjuster was pushed back with a hammer and the t-handle was removed.The height was the able to be adjusted.There was a two (2) minute surgical delay and the procedure was completed successfully.Concomitant device: unknown screwdriver (part# unknown, lot# unknown, quantity unknown).This report is for one (1) viper prime t-handle.This is report 1 of 2 for (b)(4).
Additional Manufacturer Narrative
Depuy synthese is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthese has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthese or its employees that the report constitutes an admission that the device, depuy synthese, 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 viper prime t-handle was conducted identifying that lot number mf4341501 was released in a single batch.Batch1: released on (b)(6) 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 viper prime t-handle was returned and received at us customer quality (cq).Upon visual inspection at cq, several dents were observed.These cosmetic issues are consistent with normal wear.No other issues were identified with the device.Functional test: a functional assessment was not performed on the complaint device as mating device prime stylet depth adjustor (p/n: (b)(4), lot: unk) was not returned.Dimensional inspection: a dimensional inspection for the received device was not performed since no physical damage was observed.Document/specification review: based on the date of manufacture, the current and manufactured revision of drawings were reviewed.Viper prime t-handle no design issues or discrepancies were identified.Investigation conclusion: this complaint could not be confirmed since a functional test was not possible to perfume as the mating device was not retuned.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: VIPER PRIME T-HANDLE
• Common Device Name: ORTHOPAEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 12174385
• Report Number: 1526439-2021-01410
• Device Sequence Number: 1631957
• Product Code: OLO
• UDI-Device Identifier: 10705034507620
• UDI-Public: 10705034507620
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K170937
• 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): 06/15/2021

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: 286750035
• Device Catalogue Number: 286750035
• Device Lot Number: MF4341501
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2021
• Initial Date Received by Manufacturer: 06/16/2021
• Supplement Date Received by Manufacturer: 07/26/2021
• Initial Report FDA Received Date: 07/15/2021
• Supplement Report FDA Received Date: 08/23/2021
• 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: PRIME STYLET DEPTH ADJUSTOR; UNKNOWN SCREWDRIVERS; PRIME STYLET DEPTH ADJUSTOR; UNKNOWN SCREWDRIVERS