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
Product complaint #(b)(4).Investigation summary: investigation flow: device interaction/functional.Visual inspection: the viper prime dilator sleeve (p/n: 286750020, lot #: pu140560) was returned and received at us cq.Upon visual inspection, it was observed that the snap ring component was broken and stuck inside the cannula.No other issues were observed with the returned device.Functional test: a functional test was not performed due to the returned condition of the device.The complaint can be replicated from the returned device.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.The complaint is confirmed.The device received was broken, which could have caused the complaint condition.Hence confirming the allegation.Investigation conclusion: the complaint condition is confirmed for the viper prime dilator sleeve (p/n: 286750020, lot #: pu140560).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 history lot: a review of the receiving inspection (ri) for viper prime dilator sleeve was conducted identifying that lot number pu140560 was released in a single batch.Batch1: lot qty of (b)(4) units were released on mar 23, 2019, 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.
Event or Problem Description
Device report from synthes reports an event in (b)(6) as follows: during education workshop with viper prime, we noticed that the spring in the lumen of the viper prime dilator sleeve, art.Nr 286750020 was loose inside.Therefore can the instrument not work properly, and it might also be a risk that the spring will get loose in the patient during surgery and cause problems or injury.This was an education before planned surgery, therefor there was no patient involved.This complaint involves one (1) device.This report is for (1) unk - plates.This is report 1 of 1 (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: 11330324
• Report Number: 1526439-2021-00296
• Device Sequence Number: 11021509
• Product Code: LXH
• UDI-Device Identifier: 10705034507576
• UDI-Public: (01)10705034507576
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 02/02/2021

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: PU140560
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/02/2021
• Initial Report FDA Received Date: 02/15/2021
• Patient Sequence Number: 1