MAUDE Adverse Event Report: DEPUY SPINE INC VIPER PRIME INSERTER HANDLE; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number 286750032

Device Problems Corroded (1131); Contamination /Decontamination Problem (2895)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Reporter is a synthes employee.Without a lot number, the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective, and/or preventative action is proposed.This complaint will be accounted for, and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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 Description

Device report from (b)(6) reports an event as follows: it was reported that on an unknown date in the sterilization department that four (4) handles have two (2) small screws that cannot be cleaned properly after several uses.The surface of the screws gradually becomes less smooth and "dirt" collects on them.This report is for one (1) viper prime inserter handle.This is report 4 of 4 for (b)(4).

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.H10 additional narrative: d4, d9: updated.G1: updated.H3, h6: investigation summary.Investigation flow: visual.Visual inspection: the viper prime inserter handle (part #: 286750032, lot #: mf4313803) was received at us cq.Upon visual inspection, the slot of the stylet handle set screw (part # 103185694) was covered with harden foreign substance.The substance did not appear to be corrosion as it could be removed with a push pin.No other defect could be reported.Document/specification review: based on the date of the released to the warehouse the following current and manufactured to drawings were reviewed.No design issues or discrepancies were identified.Dimensional inspection: a dimensional inspection was not performed as there was no damage that warranted a dimensional inspection.Conclusion: the overall complaint was confirmed for the viper prime inserter handle (part #: 286750032, lot #: mf4313803) as there were harden foreign material accumulated in the slot of the stylet handle set screw.It is likely that the foreign material was not coming off through the cleaning process because it hardened.Corrosion, rusting or pitting could not be confirmed.No definitive root cause could be determined based on the provided information.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 history lot: a review of the receiving inspection (ri) for viper prime inserter handle was conducted identifying that lot number mf4313803 was released in a single batch.Batch1: lot qty of (b)(4) units were released on sep 06, 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.Device history review: the ri identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer.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 INSERTER HANDLE
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 10929765
• MDR Text Key: 219381592
• Report Number: 1526439-2020-02325
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 10705034507590
• UDI-Public: 10705034507590
• Combination Product (y/n): N
• PMA/PMN Number: K170937
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 286750032
• Device Catalogue Number: 286750032
• Device Lot Number: MF4313803
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2021
• Date Manufacturer Received: 02/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1