MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH VIPER3D COMPRESSOR/DISTRACTOR; EXTRACTOR

Model Number 286740020

Device Problem Mechanical Problem (1384)

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

Event Type  malfunction  

Manufacturer Narrative

Initial reporter is a synthes employee a review of the receiving inspection (ri) for compressor/distractor rack was conducted identifying that lot number gm4059401 was released in a single batch on (b)(6) 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.A product investigation was completed: visual inspection of the complaint device showed that the rotational locking screw on secondary body is jammed and cannot be loosened.However, the pivoting sleeve was rotating freely and was not locked.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.During functional test, the device was able to lock/unlock and was functioning in all the three functions, but the rotational locking screw on secondary body is jammed and cannot be loosened.The pivoting sleeve was unable to be locked even when the rotational screw was completely tightened.The jammed rotational locking screw could have caused the complaint condition.A dimensional inspection was not performed as the internal components were inaccessible without destruction of the device.Based on the date of manufacture, the current and manufactured revision of drawings were reviewed.The complaint condition was confirmed.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 (b)(6) reports an event as follows: during an incoming inspection at the loaner department, it was noticed that screw cannot be tightened.There was no surgery or patient impact.Visual inspection of the complaint device showed that the rotational locking screw on secondary body is jammed and cannot be loosened.However, the pivoting sleeve was rotating freely and was not locked.This report is for a viper3d compressor/distractor.This is report 1 of 1 for (b)(4).

• Brand Name: VIPER3D COMPRESSOR/DISTRACTOR
• Type of Device: EXTRACTOR
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer (Section G): SENTIO (INNOVATIVE SURGICAL SOLUTIONS, LLC); 50461 west pontiac trail; wixom MI 48393
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6103142063
• MDR Report Key: 12239871
• MDR Text Key: 263911643
• Report Number: 1526439-2021-01547
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 05/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2021
• 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: 07/07/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/28/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/03/2014
• 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