MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH VIPER 2 SYSTEM COMPRESSION/DISTRACTION RACK 5.5; EXTRACTOR

Model Number 286740020

Device Problems Mechanical Problem (1384); Device-Device Incompatibility (2919)

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

Event Type  malfunction  

Manufacturer Narrative

The investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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 germany as follows: it was reported that on an unknown date, the compression instrument could not be tightened and the cogs were blocking.No surgical impact.No patient impact.No further information available.This report is for one (1) viper 2 system compression/distraction rack 5.5.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H3, h6: a product investigation was conducted.Visual inspection: the viper3d compressor/distractor (p/n: 286740020, lot #: gm5161318) was returned and received at us cq.Upon visual inspection, there were scratches on the device but have no impact on the device functionality.No other issues were observed with the returned device.Functional test: a functional test was performed, the main body of the device is jammed and does not translate smoothly in compression state.The device can only translate freely when the pinion gear is rotated.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 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.Although no definitive root-cause can be determined its possible the device experienced unintended forces.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.H3, h6: a device history record (dhr) review was conducted: 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 (b)(4) 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.

• Brand Name: VIPER 2 SYSTEM COMPRESSION/DISTRACTION RACK 5.5
• Type of Device: EXTRACTOR
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 12224842
• MDR Text Key: 263390336
• Report Number: 1526439-2021-01513
• Device Sequence Number: 1
• Product Code: HWB
• UDI-Device Identifier: 10705034214757
• UDI-Public: (01)10705034214757
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2021
• 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: 08/13/2021
• Date Manufacturer Received: 08/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1