MAUDE Adverse Event Report: DEPUY SPINE INC VIPER 2 SYSTEM COMPRESSION/DISTRACTION RACK 5.5; EXTRACTOR

Model Number 286740020

Device Problem Mechanical Problem (1384)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Upon visual inspection no damage was noted on the instrument that would contribute to the complaint condition.A functional test was performed, and the main body was seized which would prevent it from interacting properly with the rest instrument and this the complaint is confirmed.The complaint condition was confirmed for the instrument.No definitive root cause was able to be determined as the circumstances surrounding the complaint are unknown.During the investigation no unidentified product design/manufacturing issues or discrepancies were observed that may have contributed to the complaint condition.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 compressor/distractor rack was conducted identifying that lot number gm4059402 was released in a single batch.Batch1: lot qty of units were released on 04 apr 2014 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.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.

Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that during an incoming inspection, it was noticed that the instrument could not be tightened.No surgical involvement.No patient consequence.This complaint involves one (1) device.This report is for one (1) viper 2 system compression/distraction rack 5.5.This is report 1 of 1 for (b)(4).

• Brand Name: VIPER 2 SYSTEM COMPRESSION/DISTRACTION RACK 5.5
• Type of Device: EXTRACTOR
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 11769442
• MDR Text Key: 267139191
• Report Number: 1526439-2021-00882
• Device Sequence Number: 1
• Product Code: HWB
• UDI-Device Identifier: 10705034214757
• UDI-Public: (01)10705034214757
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 286740020
• Device Catalogue Number: 286740020
• Device Lot Number: GM4059402
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/08/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/04/2014
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1