MAUDE Adverse Event Report: DEPUY SPINE INC VIPER PRIME DILATOR SLEEVE; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	286750020
Medical Device Problem Code	Device Slipped (1584)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/29/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the receiving inspection (ri) for viper prime dilator sleeve was conducted identifying that lot number pu127107 was released in a single batch on january 25, 2018 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.A product investigation was completed: visual inspection of the complaint device and review of the provide image showed that the opened snap ring was not attached to the cannula and was deformed.No other defect was observed.A functional assessment was not performed with the complaint device due to the post manufacturing damage of the device.No dimensional inspection was performed due to post-manufacturing damage.The current and manufactured to drawing was reviewed; no design issues or discrepancies were identified.No root cause could definitively be determined for the reported complaint condition.This complaint is confirmed.No new, unique or different patient harms were identified as a result of this evaluation.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 on the investigation findings, it has been determined that no corrective and/or preventive 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.
Event or Problem Description
Device report from synthes (b)(6) reports an event as follows: it was reported that while using the dilatator of the viper prime dilator sleeve, a snap ring was loosened.Another device was readily available so there was no surgery delay, and the procedure was completed successfully.Visual inspection of the complaint device and review of the provide image showed that the opened snap ring was not attached to the cannula and was deformed.This report is for a viper prime dilator sleeve.This is report 1 of 1 for (b)(4).

• Brand Name: VIPER PRIME DILATOR SLEEVE
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 12526753
• Report Number: 1526439-2021-02065
• Device Sequence Number: 14511116
• Product Code: LXH
• UDI-Device Identifier: 10705034507576
• UDI-Public: (01)10705034507576
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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
• Report Date (Section B): 07/29/2021

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: 286750020
• Device Catalogue Number: 286750020
• Device Lot Number: PU127107
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/27/2021
• Initial Report FDA Received Date: 09/24/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN DILATOR
• Patient Age: 42 YR