MAUDE Adverse Event Report: DEPUY SPINE INC VIPER PRIME COMPRESSOR 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	05/24/2022
Type of Reportable Event	Malfunction
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.Additional narrative: initial reporter is a synthes employee.The device was received, the investigation is in progess, 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.
Event or Problem Description
Device report from japan reports an event as follows: it was reported that during a procedure on (b)(6) 2022, the tip of a viper prime compressor driver broke off while tightening a screw.The procedure was for implanting a stryker cage, and was completed successfully after removing the driver fragment.This report is for a viper prime compressor driver, x25.This is report 1 of 1 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: investigation summary : the product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that the tip of the viper prime comp driver, x25 was broken.The broken fragment was not returned.No other anomalies were found.A dimensional inspection was unable to be performed due to the post-manufacturing damage.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to unintended forces.A review of the receiving inspection (ri) was performed for the finished device [km904279] number, and no issues were identified.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed as the observed condition of the viper prime comp driver, x25 would contribute to the complained device issue.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 history review : a review of the receiving inspection (ri) for viper prime comp driver, x25 was conducted identifying that lot number km904279 was released in one batch; and identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer.

• Brand Name: VIPER PRIME COMPRESSOR DRIVER, X25
• Common Device Name: INSTRUMENT, COMPRESSION
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kate karberg ; chemin-blanc 38; le locle 02400 ; SZ 02400 ; 3035526892
• MDR Report Key: 14753173
• Report Number: 1526439-2022-00894
• Device Sequence Number: 16710267
• Product Code: HWN
• UDI-Device Identifier: 10705034507736
• UDI-Public: (01)10705034507736
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup

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: KM904279
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/24/2022
• Supplement Date Received by Manufacturer: 07/12/2022
• Initial Report FDA Received Date: 06/21/2022
• Supplement Report FDA Received Date: 08/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/17/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Sex: Female