MAUDE Adverse Event Report: DEPUY SPINE INC VIPER 2 SYSTEM REDUCTION THREADED POST 5.5; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	286735730
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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.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 or Problem Description
Device report from synthes reports an event in (b)(6) as follows: it was reported that on an unknown date, during the cleaning procedure it was noticed that reduction threaded post did not snap into place when placed over reduction shaft.There was no surgery or patient impact.This report involves one (1) viper 2 system reduction threaded post 5.5.This is report 1 of 2 for (b)(4).
Additional Manufacturer Narrative
Product complaint #: (b)(4).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.A review of the receiving inspection (ri) for reduction threaded post was conducted identifying that lot number mi73939 was released in a single batch.¿ batch1: lot qty of 55 units were released on 14feb2019 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 batch null, 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.Investigation summary: background: during the cleaning procedure it was noticed that reduction threaded post did not snap into place when placed over reduction shaft.No surgery impact.No patient impact.H6: investigation flow: device interaction/functional visual inspection: the reduction threaded post (p/n: 286735730, lot #: mi73939) was returned and received at us cq.Upon visual inspection, scratches were observed on the device but have no impact on the device functionality.No other issues were observed with the returned device.Functional test: a functional test was not performed as the device was returned by itself.Can the complaint be replicated with the returned device? unable to perform document/specification review based on the date of manufacture, the current and manufactured revision of drawings were reviewed viper3d threaded reduction post assembly: dwg-887027839, rev.D threaded reduction post: dwg-887027840 , rev.C complaint not confirmed.Investigation conclusion the complaint condition was not confirmed for the reduction threaded post (p/n: 286735730, lot #: mi73939).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.D4/lot number & g1/manufacturing site.

• Brand Name: VIPER 2 SYSTEM REDUCTION THREADED POST 5.5
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 11414660
• Report Number: 1526439-2021-00387
• Device Sequence Number: 4461444
• Product Code: LXH
• UDI-Device Identifier: 10705034214665
• UDI-Public: (01)10705034214665
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 02/09/2021

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: 286735730
• Device Catalogue Number: 286735730
• Device Lot Number: MI73939
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2021
• Initial Date Received by Manufacturer: 02/09/2021
• Supplement Date Received by Manufacturer: 03/29/2021
• Initial Report FDA Received Date: 03/04/2021
• Supplement Report FDA Received Date: 04/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1