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

If the information is unknown, not available or does not apply, the section/field of the form is left blank.Reporter is a j&j employee.A product investigation was conducted.Visual inspection: the viper3d compressor/distractor (p/n: 286740020, lot number: gm5161318) was received at us cq.Visual inspection of the complaint device showed the rotational locking screw on the secondary body was jammed and cannot be loosened.Also, the pivoting sleeve was observed to loose and cannot be tightened.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 secondary body is jammed and cannot be loosened.Thus, the complaint could be confirmed.Dimensional inspection: a dimensional inspection was not performed due to inaccessibility of internal components.Document/specification review: no design issues or discrepancies were identified.Yes, the rotational locking screw on secondary body is jammed.Hence confirming the allegation.Investigation conclusion: the complaint condition was confirmed for the viper3d compressor/distractor (p/n: 286740020, lot #: gm5161318).There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.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.A review of the receiving inspection (ri) for compressor/distractor rack was conducted identifying that lot number gm5161318 was released in a single batch.Batch1: lot qty of 49 units were released on 04 mar 2020 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 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 during an incoming inspection at the loaner set department it was noticed that the compression instrument cannot be tightened and the cogs are blocking.There was no surgery or patient impact.No further information available.During manufacturer's investigation of the returned device it was observed that the rotational locking screw on the secondary body was jammed and cannot be loosened.Also, the pivoting sleeve was observed to loose and cannot be tightened.This report is for one (1) viper 2 system compression/distraction rack 5.5.This is report 1 of 1 for complaint (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: 12713094
• MDR Text Key: 278833397
• Report Number: 1526439-2021-02274
• 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: 07/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2021
• 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: GM5161318
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2021
• Date Manufacturer Received: 10/26/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/04/2020
• 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