MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH VIPER PRIME COMP DRIVER, X25; INSTRUMENT COMPRESSION

Model Number	286750083
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/26/2021
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 a j&j 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 or Problem Description
Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2021 during an unknown procedure, one (1) viper prime driver and two (2) viper prime set screw inserters were broken during final tightening.There was no surgical delay.Fragments were generated and easily removed.The procedure was successfully completed using the torque handle and screwdriver of another compatible set of instruments.There was no patient consequence.Concomitant device reported: unknown locking/set screw (part# unknown, lot# unknown, quantity unknown).Unknown driver leg (part# unknown, lot# unknown, quantity unknown).Unknown solid compressor leg (part# unknown, lot# unknown, quantity unknown).Unknown torque handle (part# unknown, lot# unknown, quantity unknown).This report is for one (1) viper prime comp driver, x25.This is report 1 of 3 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.H10 additional narrative: b6; d4; d9: h3, h6: the subject device has been received, the investigation is in progress, 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.
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.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.
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.H3, h4, h6: a review of the receiving inspection (ri) for viper prime comp driver, x25 was conducted identifying that lot number km845089 was released in two batches.Batch1: lot qty of (b)(4) units were released on 15 jun 2017 with no discrepancies.Batch2: lot qty of (b)(4) units were released on 11 aug 2020 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 comp driver, x25 (p/n: 286750083, lot #: km845089) was returned and received at us customer quality (cq).Upon visual inspection, it was observed that the distal tip was broken and the broken fragment was not returned.There were scratches on the device but have no impact on the device functionality.No other issues were identified with the returned device.Device failure/defect identified? yes.Dimensional inspection: the outer diameter was measured to be within the specification per drawing.Document/specification review: based on the date of manufacture, the current and manufactured revision of drawings were reviewed.Viper 1-step compressor driver with integral handle.Viper 1-step compressor driver.Complaint confirmed? yes, the device received was broken.Hence confirming the allegation.Investigation conclusion the complaint condition was confirmed for the viper prime comp driver, x25 (p/n: 286750083, lot #: km845089).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 COMP DRIVER, X25
• Common Device Name: INSTRUMENT COMPRESSION
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle MA 02400 ; SZ 02400
• MDR Report Key: 12033403
• Report Number: 1526439-2021-01264
• Device Sequence Number: 14446924
• Product Code: HWN
• UDI-Device Identifier: 10705034507736
• UDI-Public: 10705034507736
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• 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,Followup,Followup
• Report Date (Section B): 05/27/2021

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: 286750083
• Device Catalogue Number: 286750083
• Device Lot Number: KM845089
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2021
• Initial Date Received by Manufacturer: 05/27/2021
• Supplement Date Received by Manufacturer: 07/05/2021; 08/05/2021; 08/11/2021
• Initial Report FDA Received Date: 06/21/2021
• Supplement Report FDA Received Date: 08/02/2021; 08/06/2021; 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: UNKNOWN DRIVER LEG; UNKNOWN LOCKING/SET SCREWS; UNKNOWN SOLID COMPRESSOR LEG; UNKNOWN TORQUE DEVICES; VIPER PRIME SET SCRW INSERT; VIPER PRIME SET SCRW INSERT