MAUDE Adverse Event Report: DEPUY SPINE INC VIPER3D COMPRESSOR/DISTRACTOR; EXTRACTOR

Model Number 286740020

Device Problems Mechanical Problem (1384); Appropriate Term/Code Not Available (3191)

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

Event Type  malfunction  

Manufacturer Narrative

Occupation: reporter is a synthes employee.A review of the receiving inspection (ri) for compressor/distractor rack was conducted identifying that lot number gm5161309 was released in two batches.Batch1: lot qty of (b)(4) units were released on july 26, 2019 with no discrepancies.Batch2: lot qty of (b)(4) units were released on october 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.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 viper3d compressor/distractor (p/n: 286740020, lot #: gm5161309) was returned and received at us customer quality (cq).Visual inspection of the complaint device showed that the rotational locking screw on main body is jammed and cannot be loosened to rotate the pivoting sleeve.Additionally, slight scratches were observed on the device but has no impact on the device functionality.No other issues were identified with the returned device.Functional test: during functional test, the device was able to lock/unlock and was functioning in all the three functions (d, n and c), but the rotational locking screw on main body is jammed and cannot be loosened to rotate the pivoting sleeve.This could have caused the complaint condition.Can the complaint be replicated with the returned device? yes.Dimensional inspection: a dimensional inspection was not performed as the internal components were inaccessible without destruction of the device.Document/specification review based on the date of manufacture, the current and manufactured revision of drawings were reviewed.Viper 3d compressor/distractor assembly.Complaint confirmed? yes, the rotational locking screw on the main body is jammed.Hence confirming the allegation.Investigation conclusion: the complaint condition was confirmed for the viper3d compressor/distractor.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 the damaged internal components or debris ingress.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 Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that on an unknown date, during the kitting process it was noticed that the instrument could not be tightened.There was no impact to a surgery.There was no patient involvement.This report involves one (1) viper 2 system compression/distraction rack 5.5.This is report 1 of 1 for (b)(4).

• Brand Name: VIPER3D COMPRESSOR/DISTRACTOR
• Type of Device: EXTRACTOR
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): BRIDGEWATER DISTRIBUTION; 50 scotland boulevard; bridgewater MA 02324
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6103142063
• MDR Report Key: 12226329
• MDR Text Key: 263474310
• Report Number: 1526439-2021-01521
• Device Sequence Number: 1
• Product Code: HWB
• UDI-Device Identifier: 10705034214757
• UDI-Public: (01)10705034214757
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2021
• 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: GM5161309
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2021
• Date Manufacturer Received: 07/22/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/26/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1