MAUDE Adverse Event Report: DEPUY SPINE INC VIPER PRIME DILATOR SLEEVE; MISC ORTHO SURGICAL INSTR

Model Number	286750020
Medical Device Problem Code	Device Slipped (1584)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reporter is a synthes employee.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.Batch1: lot qty of (b)(4)units were released 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.Visual inspection: the complaint device viper prime dilator sleeve was returned to us customer quality (cq) west chester for investigation.The snap ring on the sleeve has come off and got lodged.There are no other visual damage or defects on the part.Functional test: a functional test was not performed as visually it can be verified that snap ring has gotten stuck inside.Can the complaint be replicated from the returned device? yes.Dimensional inspection: no dimensional inspection can be performed due to post-manufacturing damage.Furthermore, the complaint relevant dimensions cannot be checked for dimensional accuracy, because of the design of the device.Document/specification review based on the date of manufacture, the current and manufactured revision of drawings were reviewed.Viper prime cannula: current and manufactured revisions.Complaint confirmed? yes, complaint condition can be confirmed based on the available information.Investigation conclusion: the snap ring on the viper prime dilator sleeve had loosen.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.The potential cause could be due to unintended forces applied to the device.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.
Event or Problem Description
Device report from synthes reports an event in the (b)(6) as follows: it was reported that on an unknown date, during demo training the metal spring component came loose and the instrument can no longer be used.This report involves one (1) viper prime dilator sleeve.This is report 1 of 1 for (b)(4).

• Brand Name: VIPER PRIME DILATOR SLEEVE
• Common Device Name: MISC ORTHO SURGICAL INSTR
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 12482432
• Report Number: 1526439-2021-02027
• Device Sequence Number: 14415082
• Product Code: LXH
• UDI-Device Identifier: 10705034507576
• UDI-Public: 10705034507576
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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
• Type of Report: Initial
• Report Date (Section B): 06/23/2021

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: 08/19/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/20/2021
• Initial Report FDA Received Date: 09/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1